Trial Outcomes & Findings for Abituzumab in SSc-ILD (NCT NCT02745145)
NCT ID: NCT02745145
Last Updated: 2019-06-18
Results Overview
FVC was the maximum amount of air exhaled from the lungs after taking the deepest breath possible. The FVC assessments were done using spirometry. Change from baseline in fvc at week 52 was reported.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline, Week 52
Results posted on
2019-06-18
Participant Flow
The study enrolled 24 participants and was early terminated due to the difficulties experienced in identifying participants who meet the eligibility criteria of the trial.
Participant milestones
| Measure |
Placebo
Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 500 Milligrams (mg)
Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 1500 mg
Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
9
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
9
|
Reasons for withdrawal
| Measure |
Placebo
Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 500 Milligrams (mg)
Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 1500 mg
Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Progressive disease
|
0
|
0
|
1
|
|
Overall Study
Withdrew consent
|
1
|
1
|
1
|
|
Overall Study
Study Termination
|
8
|
3
|
7
|
Baseline Characteristics
Abituzumab in SSc-ILD
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 500 Milligrams (mg)
n=5 Participants
Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 1500 mg
n=9 Participants
Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
60 Years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
55 Years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
55 Years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: Modified intent-to-treat (mITT) population was defined as all randomized participants who received at least 1 dose of study drug (including placebo). Here, "Overall Number of Participants Analyzed" signified participants evaluable for the outcome measure. All participants for abituzumab 500 mg arm dropped out before the analysis was conducted.
FVC was the maximum amount of air exhaled from the lungs after taking the deepest breath possible. The FVC assessments were done using spirometry. Change from baseline in fvc at week 52 was reported.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 500 mg
Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 1500 mg
n=1 Participants
Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
|---|---|---|---|
|
Change From Baseline in Absolute Forced Vital Capacity (FVC) at Week 52
|
-130 milliliters
Standard Deviation 56.6
|
—
|
-50 milliliters
Standard Deviation NA
Standard deviation was not estimable as there was only one participant evaluable for the arm.
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo). Here, "Overall Number of Participants Analyzed" signified number of participants evaluable for the outcome measure. All participants for abituzumab 500 mg arm dropped out before the analysis was conducted.
Mahler's TDI was an interview-administered instrument that allows participants to assess their level of dyspnea which was assessed by functional impairment, magnitude of task and magnitude of effort. Scores for each subscale range from -3 to +3 so that the TDI focal score ranges from -9 (major deterioration) to +9 (major improvement). For all subscale scores and the TDI focal score a higher value indicates a better outcome.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 500 mg
Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 1500 mg
n=1 Participants
Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
|---|---|---|---|
|
Change From Baseline in Dyspnea as Measured by the Mahler's Transition Dyspnea Index (TDI) at Week 52
|
3 Score on a scale
Standard Deviation NA
Standard deviation was not estimable as there was only one participant evaluable for the arm.
|
—
|
4 Score on a scale
Standard Deviation NA
Standard deviation was not estimable as there was only one participant evaluable for the arm.
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo). Here, "Overall Number of Participants Analyzed" signified number of participants evaluable for the outcome measure. All participants for abituzumab 500 mg arm dropped out before the analysis was conducted.
The SGRQ assesses health-related quality of life in participants with chronic pulmonary disease by evaluating 3 health domains: symptoms (distress caused by respiratory symptoms); activity (effects of disturbances on mobility and physical activity); and impacts (the effect of disease on factors such as employment, personal control of one's health, and need for medication). A composite total score is derived as the weighted sum of domain scores for symptoms, activity, and impact (0=the best possible score and 100=the worst possible score). A reduction in score of 4 units is generally recognized as a clinically meaningful improvement in quality of life.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 500 mg
Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 1500 mg
n=1 Participants
Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
|---|---|---|---|
|
Absolute Change From Baseline in St. George Respiratory Questionnaire (SGRQ) Total Score at Week 52
|
6.4 Scores on a scale
Standard Deviation NA
Standard deviation was not estimable as there was only one participant evaluable for the arm.
|
—
|
1.4 Scores on a scale
Standard Deviation NA
Standard deviation was not estimable as there was only one participant evaluable for the arm.
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: mITT diffuse cutaneous systemic sclerosis population from mITT analysis set who had diffuse cutaneous skin involvement at baseline. Here, "Overall Number of Participants Analyzed" signified participants evaluable for the outcome measure. All participants for abituzumab 500 mg and abituzumab 1500 mg arm dropped out before the analysis was conducted.
The Modified Rodnan Skin Score (mRSS) measures dermal skin thickness through the examination of 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (in pairs), and face, chest, and abdomen. The skin score is evaluated by manual palpation in each of these areas. The skin score is 0 for uninvolved skin, 1 for mild thickening, 2 for moderate thickening, and 3 for severe thickening (hidebound skin). The total skin score is the sum of the skin scores of the individual areas where the minimum score is 0 and the maximum score is 51. A higher score indicates greater severity of disease.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 500 mg
Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 1500 mg
Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
|---|---|---|---|
|
Absolute Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 52 in Participants With Diffuse Cutaneous Skin Involvement at Baseline
|
0 Scores on a scale
Standard Deviation NA
Standard deviation was not estimable as there was only one participant evaluable for the arm.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo). Here, "Overall Number of Participants Analyzed" signified number of participants evaluable for the outcome measure. All participants for abituzumab 500 mg arm dropped out before the analysis was conducted.
Absolute change from baseline in QLF score at week 52 was calculated as the difference of the QLF score at week 52 minus the QLF score at baseline divided in the region of highest baseline severity at Week 52 .The QLF score itself ranges from 0 to 100, where greater values represent a greater amount of lung fibrosis and are considered a worse health status.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 500 mg
Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 1500 mg
n=1 Participants
Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
|---|---|---|---|
|
Absolute Change From Baseline in Quantitative Lung Fibrosis (QLF) in the Region of Highest Baseline Severity at Week 52
|
6.29 Scores on a scale
Standard Deviation 2.638
|
—
|
-2.27 Scores on a scale
Standard Deviation NA
Standard deviation was not estimable as there was only one participant evaluable for the arm.
|
SECONDARY outcome
Timeframe: Time from date of randomization until death, assessed up to 2 yearsPopulation: mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo).
Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number participants who died and number of censored participants.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 500 mg
n=5 Participants
Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 1500 mg
n=9 Participants
Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
|---|---|---|---|
|
Overall Survival (OS)
Number of deaths
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Overall Survival (OS)
Number for censored
|
10 Participants
|
4 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: upto Week 52Population: mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo).
Clinically Meaningful Progression SSc-ILD was defined as one of the following (in the absence of causative intercurrent illness) on at least 2 occasions within approximately 4 weeks (per Outcome Measures in Rheumatology criteria): Relative decrease from baseline in forced vital capacity (FVC) % predicted greater than or equal to (\>=)10%; Relative decrease from baseline in FVC % predicted of \>=5% to less than (\<) 10% and relative decrease from baseline in Diffusion capacity of the lung for carbon monoxide % predicted \>=15%.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 500 mg
n=5 Participants
Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 1500 mg
n=9 Participants
Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
|---|---|---|---|
|
Number of Participants With Clinically Meaningful Progression of Systemic Sclerosis (SSc) by Meeting Criterion 1 (Interstitial Lung Disease [ILD])
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: upto Week 52Population: mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo).
Clinically Meaningful Progression SSc other than ILD was defined as new onset of one or more of the following: Scleroderma renal crisis; Left ventricular failure (defined as ejection fraction \<=45%); Pulmonary arterial hypertension requiring treatment.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 500 mg
n=5 Participants
Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 1500 mg
n=9 Participants
Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
|---|---|---|---|
|
Number of Participants With Clinically Meaningful Progression of Systemic Sclerosis (SSc) by Meeting Criterion 2 (SSc Progression Other Than ILD)
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: upto Week 52Population: mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo).
Participants meeting one or both of the below criteria was considered as having clinically meaningful disease progression. Clinically Meaningful SSc-ILD defined as one of the following (in the absence of causative intercurrent illness) on at least 2 occasions within approximately 4 weeks (per Outcome Measures in Rheumatology criteria): Relative decrease from baseline in forced vital capacity (FVC) % predicted greater than or equal to (\>=)10%; Relative decrease from baseline in FVC % predicted of \>=5% to less than (\<) 10% and relative decrease from baseline in Diffusion capacity of the lung for carbon monoxide % predicted \>=15%. Clinically Meaningful SSc progression other than ILD defined as new onset of one or more of the following: Scleroderma renal crisis; Left ventricular failure (defined as ejection fraction \<=45%); Pulmonary arterial hypertension requiring treatment.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 500 mg
n=5 Participants
Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 1500 mg
n=9 Participants
Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
|---|---|---|---|
|
Number of Participants With Clinically Meaningful Progression
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: upto Week 52Population: mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo).
FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. The FVC assessments were done using spirometry.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 500 mg
n=5 Participants
Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 1500 mg
n=9 Participants
Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
|---|---|---|---|
|
Number of Participants With Absolute Decrease From Baseline of FVC Percentage (%) Predicted Greater Than or Equal to (>=) 10% on 2 or More Consecutive Occasions at Least 4 Weeks Apart
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Abituzumab 500 Milligrams (mg)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Abituzumab 1500 mg
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=10 participants at risk
Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 500 Milligrams (mg)
n=5 participants at risk
Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 1500 mg
n=9 participants at risk
Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
|---|---|---|---|
|
General disorders
Disease progression
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Infections and infestations
Device related infection
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Nervous system disorders
Small fibre neuropathy
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Investigations
Neutrophil count increased
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
Other adverse events
| Measure |
Placebo
n=10 participants at risk
Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 500 Milligrams (mg)
n=5 participants at risk
Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
Abituzumab 1500 mg
n=9 participants at risk
Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Endocrine disorders
Eye pain
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
30.0%
3/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
33.3%
3/9 • From start of study drug administration up to 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
22.2%
2/9 • From start of study drug administration up to 2 years
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
General disorders
Asthenia
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
General disorders
Fatigue
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
22.2%
2/9 • From start of study drug administration up to 2 years
|
|
General disorders
Generalised oedema
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
General disorders
Impaired healing
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
General disorders
Oedema peripheral
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
22.2%
2/9 • From start of study drug administration up to 2 years
|
|
General disorders
Pyrexia
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Infections and infestations
Bronchitis
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Infections and infestations
Gastroenteritis
|
40.0%
4/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Infections and infestations
Gastrointestinal bacterial overgrowth
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Gastrointestinal disorders
Influenza
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
22.2%
2/9 • From start of study drug administration up to 2 years
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Investigations
Blood urine present
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Investigations
Electrocardiogram abnormal
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Investigations
Hepatic enzyme increased
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Investigations
Neutrophil count increased
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Investigations
Platelet count increased
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Investigations
Protein urine present
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Investigations
Weight decreased
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Investigations
White blood cell count increased
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
22.2%
2/9 • From start of study drug administration up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
22.2%
2/9 • From start of study drug administration up to 2 years
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Nervous system disorders
Lethargy
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Nervous system disorders
Migraine
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Nervous system disorders
Sciatica
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Nervous system disorders
Somnolence
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
3/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
33.3%
3/9 • From start of study drug administration up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
22.2%
2/9 • From start of study drug administration up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin hypertrophy
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
11.1%
1/9 • From start of study drug administration up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
22.2%
2/9 • From start of study drug administration up to 2 years
|
|
Vascular disorders
Hot flush
|
0.00%
0/10 • From start of study drug administration up to 2 years
|
20.0%
1/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • From start of study drug administration up to 2 years
|
0.00%
0/5 • From start of study drug administration up to 2 years
|
0.00%
0/9 • From start of study drug administration up to 2 years
|
Additional Information
Communication Center
Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place