Trial Outcomes & Findings for A Study of AL101 Monotherapy in Patients With Notch Activated Triple Negative Breast Cancer (NCT NCT04461600)
NCT ID: NCT04461600
Last Updated: 2024-02-12
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
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
12 month
Results posted on
2024-02-12
Participant Flow
Participant milestones
| Measure |
AL101 4mg
AL101 is an inhibitor of gamma secretase-mediated Notch signaling. 4mg of AL101 was administered using an IV infusion pump over 60 minutes, once a week.
|
AL101 6mg
AL101 is an inhibitor of gamma secretase-mediated Notch signaling. 6mg of AL101 was administered using an IV infusion pump over 60 minutes, once a week.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
6
|
|
Overall Study
COMPLETED
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
AL101 4mg
AL101 is an inhibitor of gamma secretase-mediated Notch signaling. 4mg of AL101 was administered using an IV infusion pump over 60 minutes, once a week.
|
AL101 6mg
AL101 is an inhibitor of gamma secretase-mediated Notch signaling. 6mg of AL101 was administered using an IV infusion pump over 60 minutes, once a week.
|
|---|---|---|
|
Overall Study
Death
|
6
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
19 patients were enrolled, only 18 were treated.
Baseline characteristics by cohort
| Measure |
AL101 4mg
n=12 Participants
AL101 is an inhibitor of gamma secretase-mediated Notch signaling. 4mg of AL101 was administered using an IV infusion pump over 60 minutes, once a week.
|
AL101 6mg
n=6 Participants
AL101 is an inhibitor of gamma secretase-mediated Notch signaling. 6mg of AL101 was administered using an IV infusion pump over 60 minutes, once a week.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
48 years
n=5 Participants
|
45 years
n=7 Participants
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • 19 patients were enrolled, only 18 were treated.
|
0 Participants
n=7 Participants • 19 patients were enrolled, only 18 were treated.
|
0 Participants
n=5 Participants • 19 patients were enrolled, only 18 were treated.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants • 19 patients were enrolled, only 18 were treated.
|
0 Participants
n=7 Participants • 19 patients were enrolled, only 18 were treated.
|
1 Participants
n=5 Participants • 19 patients were enrolled, only 18 were treated.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • 19 patients were enrolled, only 18 were treated.
|
0 Participants
n=7 Participants • 19 patients were enrolled, only 18 were treated.
|
0 Participants
n=5 Participants • 19 patients were enrolled, only 18 were treated.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • 19 patients were enrolled, only 18 were treated.
|
1 Participants
n=7 Participants • 19 patients were enrolled, only 18 were treated.
|
1 Participants
n=5 Participants • 19 patients were enrolled, only 18 were treated.
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants • 19 patients were enrolled, only 18 were treated.
|
5 Participants
n=7 Participants • 19 patients were enrolled, only 18 were treated.
|
14 Participants
n=5 Participants • 19 patients were enrolled, only 18 were treated.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • 19 patients were enrolled, only 18 were treated.
|
0 Participants
n=7 Participants • 19 patients were enrolled, only 18 were treated.
|
0 Participants
n=5 Participants • 19 patients were enrolled, only 18 were treated.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants • 19 patients were enrolled, only 18 were treated.
|
0 Participants
n=7 Participants • 19 patients were enrolled, only 18 were treated.
|
2 Participants
n=5 Participants • 19 patients were enrolled, only 18 were treated.
|
|
Region of Enrollment
Belgium
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthPopulation: Efficacy Evaluable Analysis Set
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 |
AL101 6mg
n=3 Participants
AL101 is an inhibitor of gamma secretase-mediated Notch signaling. 6mg of AL101 was administered using an IV infusion pump over 60 minutes, once a week.
|
AL101 4mg
n=10 Participants
AL101 is an inhibitor of gamma secretase-mediated Notch signaling. 4mg of AL101 was administered using an IV infusion pump over 60 minutes, once a week.
|
|---|---|---|
|
Overall Response Rate (ORR)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Efficacy Evaluable Analysis Set
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 |
AL101 6mg
n=3 Participants
AL101 is an inhibitor of gamma secretase-mediated Notch signaling. 6mg of AL101 was administered using an IV infusion pump over 60 minutes, once a week.
|
AL101 4mg
n=10 Participants
AL101 is an inhibitor of gamma secretase-mediated Notch signaling. 4mg of AL101 was administered using an IV infusion pump over 60 minutes, once a week.
|
|---|---|---|
|
Clinical Benefit Response Rate (CBR)
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Duration of response data was not collected as there were no patients with either CR or PR
Duration of response (DOR) is defined as the time from randomization to disease progression or death in patients who achieve complete or partial response.
Outcome measures
Outcome data not reported
Adverse Events
AL101 6mg
Serious events: 5 serious events
Other events: 6 other events
Deaths: 5 deaths
AL101 4mg
Serious events: 2 serious events
Other events: 12 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
AL101 6mg
n=6 participants at risk
AL101 is an inhibitor of gamma secretase-mediated Notch signaling.
.
|
AL101 4mg
n=12 participants at risk
AL101 is an inhibitor of gamma secretase-mediated Notch signaling.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Cardiac disorders
Cardiac arrest
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
General disorders
Pyrexia
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
Other adverse events
| Measure |
AL101 6mg
n=6 participants at risk
AL101 is an inhibitor of gamma secretase-mediated Notch signaling.
.
|
AL101 4mg
n=12 participants at risk
AL101 is an inhibitor of gamma secretase-mediated Notch signaling.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
83.3%
5/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
41.7%
5/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
41.7%
5/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
25.0%
3/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
25.0%
3/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
General disorders
Fatigue
|
33.3%
2/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
41.7%
5/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
General disorders
Asthenia
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
33.3%
4/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
General disorders
Pyrexia
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
25.0%
3/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
General disorders
Pain
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
General disorders
Chest pain
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
General disorders
Chills
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
General disorders
Device related thrombosis
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
General disorders
Face oedema
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
General disorders
Localised oedema
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
General disorders
Mucosal dryness
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
50.0%
6/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
25.0%
3/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Nervous system disorders
Anosmia
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Nervous system disorders
Cerebral haemorrhage
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Nervous system disorders
Dystonia
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Nervous system disorders
Taste disorder
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
50.0%
3/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
25.0%
3/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
25.0%
3/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
3/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
25.0%
3/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Investigations
Blood creatine increased
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Investigations
Blood potassium decreased
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Psychiatric disorders
Insomnia
|
33.3%
2/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
25.0%
3/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Infections and infestations
Oral candidiasis
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Infections and infestations
Sputum purulent
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
25.0%
3/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
16.7%
2/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Cardiac disorders
Cardiac arrest
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Eye disorders
Photophobia
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
0.00%
0/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Endocrine disorders
Cushing's syndrome
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
8.3%
1/12 • 1 year and 3 months
The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place