Trial Outcomes & Findings for Efficacy of Medical Treatment With SOM230 LAR in Patients With Primary Inoperable Thymoma and/or With Local Recurrent Thymoma to Reduce Tumor Size (NCT NCT02021942)
NCT ID: NCT02021942
Last Updated: 2018-02-05
Results Overview
To evaluate whether SOM230 LAR is effective in patients with inoperable thymoma with respect to shrinkage of tumor volume. Response is defined as the decrease in tumor volume of 20 % at EOS as compared to baseline. Tumor shrinkage is assessed by CT or MRI.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
at least 6 months
Results posted on
2018-02-05
Participant Flow
This monocentric trial was conducted in Regensburg, Germany. The patients were asked for study participation by the investigator.
Participant milestones
| Measure |
SOM230 LAR
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Medical Treatment With SOM230 LAR in Patients With Primary Inoperable Thymoma and/or With Local Recurrent Thymoma to Reduce Tumor Size
Baseline characteristics by cohort
| Measure |
SOM230 LAR
n=16 Participants
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
|
|---|---|
|
Age, Continuous
|
52.6 years
STANDARD_DEVIATION 12.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
16 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: at least 6 monthsPopulation: Initial diagnosis of thymoma for one patient could not be confirmed, but a squamous cell carcinoma was diagnosed by the central pathologist. Tumor voume was 320.99 cm\^3 at screening. Tumor size was reduced to 176.87 cm\^3 at month 2 (-44.9 % compared to baseline). At month 4 (EOS) tumor volume was slightly increased compared to month 2 (189 cm\^3).
To evaluate whether SOM230 LAR is effective in patients with inoperable thymoma with respect to shrinkage of tumor volume. Response is defined as the decrease in tumor volume of 20 % at EOS as compared to baseline. Tumor shrinkage is assessed by CT or MRI.
Outcome measures
| Measure |
SOM230 LAR
n=16 Participants
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
|
|---|---|
|
Percent Change in Tumor Volume From Baseline to EOS
|
-37.38 percentage of tumor volume
Interval -60.88 to -13.88
|
SECONDARY outcome
Timeframe: at least 6 monthsTo evaluate the resection status based on the categories R0, R1 and ≥ R2 at EOS using CT or MRI imaging. R0 resection means no residual tumor tissue (best status); R1 indicates microscopic residual tumor tissue and R2 indicates macroscopic residual tumor tissue (worst status).
Outcome measures
| Measure |
SOM230 LAR
n=16 Participants
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
|
|---|---|
|
Tumor Resection Status
Surgery performed with resection status R0
|
6 Participants
|
|
Tumor Resection Status
Surgery performed with resection status R1
|
4 Participants
|
|
Tumor Resection Status
No surgery performed
|
6 Participants
|
SECONDARY outcome
Timeframe: at least 6 monthsPopulation: Operability of the tumor at the EOS was based on the decision of the treating surgeon. In addition the response criteria had to be fulfilled. The tumors of 11 patients (68.75%) were operable. One of these patients decided not to undergo surgery. Tumors of 5 patients were inoperable (31.25%) at the EOS.
Assessment if patients reaching operability at the EOS.
Outcome measures
| Measure |
SOM230 LAR
n=16 Participants
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
|
|---|---|
|
Assessment of Tumor Operability
Tumor assesed as operable.
|
11 Participants
|
|
Assessment of Tumor Operability
Tumor assesed as not operable.
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at least 6 monthsOutcome measures
| Measure |
SOM230 LAR
n=16 Participants
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
|
|---|---|
|
Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Number of participants with AEs
|
16 Participants
|
|
Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Number of participants with SAEs
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at least 6 monthsMG severity status is assessed by determining Titin-antibody status at Baseline and EOS.
Outcome measures
| Measure |
SOM230 LAR
n=16 Participants
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
|
|---|---|
|
Assessment of Myasthenia Gravis (MG) Status by Determining Titin-antibody Status
Missing data at baseline or EOS
|
8 Participants
|
|
Assessment of Myasthenia Gravis (MG) Status by Determining Titin-antibody Status
Change from negative to negative
|
4 Participants
|
|
Assessment of Myasthenia Gravis (MG) Status by Determining Titin-antibody Status
Change from negative to positive
|
0 Participants
|
|
Assessment of Myasthenia Gravis (MG) Status by Determining Titin-antibody Status
Change from positive to positive
|
2 Participants
|
|
Assessment of Myasthenia Gravis (MG) Status by Determining Titin-antibody Status
Change from positive to negative
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at least 6 monthsMG severity status is assessed by measuring ACHR-antibody concentrations at Baseline and EOS.
Outcome measures
| Measure |
SOM230 LAR
n=16 Participants
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
|
|---|---|
|
Assessment of Myasthenia Gravis (MG) Status by Measuring ACHR-antibody Concentrations
ACHR-antibody level increased
|
1 Participants
|
|
Assessment of Myasthenia Gravis (MG) Status by Measuring ACHR-antibody Concentrations
Missing data at baseline or EOS
|
8 Participants
|
|
Assessment of Myasthenia Gravis (MG) Status by Measuring ACHR-antibody Concentrations
ACHR-antibody level decreased
|
4 Participants
|
|
Assessment of Myasthenia Gravis (MG) Status by Measuring ACHR-antibody Concentrations
ACHR-antibody level constant
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at least 6 monthsPopulation: 5 out of 16 patients were excluded from analysis due to missing EOS data.
Health related quality of life information was collected at Baseline and EOS using SF-36 questionnaire. Questionnaires had to be completed by the patients. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Patient reported answers were transformed into domain scores according to the guidelines provided by RAND/MOS. Statistical significance of the result was tested with a paired Wilcoxon rang sum test with a significance level of 0.05 considering only paired values (n=11) using PSPP Version 0.10.1.
Outcome measures
| Measure |
SOM230 LAR
n=11 Participants
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
|
|---|---|
|
Health Related Quality of Life
Change in health (general) (EOS)
|
50.0 units on a scale
Standard Deviation 15.8
|
|
Health Related Quality of Life
Physical function (SCR)
|
58.6 units on a scale
Standard Deviation 28.9
|
|
Health Related Quality of Life
Physical function (EOS)
|
49.1 units on a scale
Standard Deviation 25.6
|
|
Health Related Quality of Life
Role limitations due to physical health (SCR)
|
31.8 units on a scale
Standard Deviation 38.9
|
|
Health Related Quality of Life
Role limitations due to physical health (EOS)
|
34.1 units on a scale
Standard Deviation 45.1
|
|
Health Related Quality of Life
Pain (SCR)
|
57.3 units on a scale
Standard Deviation 28.8
|
|
Health Related Quality of Life
Pain (EOS)
|
52.3 units on a scale
Standard Deviation 35.7
|
|
Health Related Quality of Life
General health (SCR)
|
53.2 units on a scale
Standard Deviation 12.9
|
|
Health Related Quality of Life
General health (EOS)
|
47.1 units on a scale
Standard Deviation 14.5
|
|
Health Related Quality of Life
Energy/Fatigue (SCR)
|
43.6 units on a scale
Standard Deviation 15.5
|
|
Health Related Quality of Life
Energy/Fatigue (EOS)
|
39.2 units on a scale
Standard Deviation 21.3
|
|
Health Related Quality of Life
Social functioning (SCR)
|
61.4 units on a scale
Standard Deviation 27.6
|
|
Health Related Quality of Life
Social functioning (EOS)
|
60.2 units on a scale
Standard Deviation 30.5
|
|
Health Related Quality of Life
Role limitations due to emotional problems (SCR)
|
63.6 units on a scale
Standard Deviation 45.8
|
|
Health Related Quality of Life
Role limitations due to emotional problems (EOS)
|
60.6 units on a scale
Standard Deviation 44.3
|
|
Health Related Quality of Life
Emotional well-being (SCR)
|
60.4 units on a scale
Standard Deviation 18.7
|
|
Health Related Quality of Life
Emotional well-being (EOS)
|
56.6 units on a scale
Standard Deviation 20.9
|
|
Health Related Quality of Life
Change in health (general) (SCR)
|
38.6 units on a scale
Standard Deviation 20.5
|
Adverse Events
SOM230 LAR
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOM230 LAR
n=16 participants at risk
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
|
|---|---|
|
General disorders
Systemic inflammatory response syndrome
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
General disorders
Non-cardiac chest pain
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Infections and infestations
Sepsis
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Injury, poisoning and procedural complications
Spinal fracutre
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
18.8%
3/16 • Number of events 3 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Vascular disorders
Embolism
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Vascular disorders
Venous thrombosis
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
Other adverse events
| Measure |
SOM230 LAR
n=16 participants at risk
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
18.8%
3/16 • Number of events 3 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Endocrine disorders
Cushing's syndrome
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Eye disorders
Cataract
|
12.5%
2/16 • Number of events 2 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
62.5%
10/16 • Number of events 12 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.8%
3/16 • Number of events 4 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Number of events 2 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Gastrointestinal disorders
Abnormal faeces
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
General disorders
Chest pain
|
18.8%
3/16 • Number of events 3 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
General disorders
Influenza like illness
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
General disorders
Malaise
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
General disorders
Oedema peripheral
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
General disorders
Peripheral swelling
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
General disorders
Pyrexia
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Immune system disorders
Immunodeficiency
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Infections and infestations
Cystitis
|
12.5%
2/16 • Number of events 2 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
2/16 • Number of events 2 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Infections and infestations
Skin infection
|
12.5%
2/16 • Number of events 2 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Infections and infestations
Bacterial infection
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Infections and infestations
Oral candidiasis
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Infections and infestations
Oral herpes
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Infections and infestations
Penile infection
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Infections and infestations
Vaginal infection
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.5%
2/16 • Number of events 2 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Investigations
Glycosylated haemoglobin increased
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Investigations
Troponin increased
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Investigations
Weight decreased
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.0%
4/16 • Number of events 12 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
12.5%
2/16 • Number of events 2 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Metabolism and nutrition disorders
Gout
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
18.8%
3/16 • Number of events 3 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
12.5%
2/16 • Number of events 2 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Nervous system disorders
Dysgeusia
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Renal and urinary disorders
Glycosuria
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Renal and urinary disorders
Haematuria
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16 • Number of events 2 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
|
Vascular disorders
Flushing
|
6.2%
1/16 • Number of events 1 • Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
|
Additional Information
Prof. Dr. Berthold Schalke
Klinik und Poliklinik für Neurologie der Universitaet Regensburg
Phone: +49 941 941
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place