Trial Outcomes & Findings for Response to Kuvan® in Subjects With Phenylketonuria (PKU) in a 4 Weeks Testing Period (NCT NCT01082328)
NCT ID: NCT01082328
Last Updated: 2014-02-27
Results Overview
Response to treatment was defined as 30 percent reduction from Baseline in blood phenylalanine (Phe) Level during the 28 +/- 1 days.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
59 participants
Primary outcome timeframe
Baseline up to Day 28 +/- 1
Results posted on
2014-02-27
Participant Flow
Participant milestones
| Measure |
Kuvan®
Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
|
|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
58
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Kuvan®
Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Response to Kuvan® in Subjects With Phenylketonuria (PKU) in a 4 Weeks Testing Period
Baseline characteristics by cohort
| Measure |
Kuvan®
n=59 Participants
Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
|
|---|---|
|
Age, Continuous
|
21.0 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 28 +/- 1Population: Full analysis set (FAS) population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®.
Response to treatment was defined as 30 percent reduction from Baseline in blood phenylalanine (Phe) Level during the 28 +/- 1 days.
Outcome measures
| Measure |
Kuvan®
n=59 Participants
Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
|
|---|---|
|
Percentage of Participants With at Least 30 Percent Reduction From Baseline in Blood Phenylalanine (Phe) Level
|
75 Percentage of participants
Interval 62.0 to 85.0
|
SECONDARY outcome
Timeframe: Baseline up to Day 42 +/- 3Population: Safety population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®.
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
Outcome measures
| Measure |
Kuvan®
n=59 Participants
Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
|
|---|---|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent Adverse Events, Treatment Related Adverse Events and AEs Leading to Withdrawal
AEs
|
58 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent Adverse Events, Treatment Related Adverse Events and AEs Leading to Withdrawal
Treatment Emergent AEs
|
57 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent Adverse Events, Treatment Related Adverse Events and AEs Leading to Withdrawal
Treatment Related AEs
|
36 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent Adverse Events, Treatment Related Adverse Events and AEs Leading to Withdrawal
AEs leading to withdrawal
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 28 +/- 1Population: FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®.
Early responders defined as percentage of participants with at least 30 percent reduction in Phe levels within the first seven days of treatment. Late responders defined as percentage of participants with less than 30 percent reduction in Phe levels within first seven days of treatment, but at least 30 percent reduction in Phe levels within 28 +/- 1 days of treatment. Partial responders defined as percentage of participants with Phe levels reduction between 10 and 30 percent at any blood measurement within the 28 +/- 1 days of treatment. Non-responders defined as percentage of participants with a Phe level reduction of less than 10 percent within 28 +/- 1 days.
Outcome measures
| Measure |
Kuvan®
n=59 Participants
Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
|
|---|---|
|
Percentage of Early-, Late-, Partial-Responders and Non-responders to Treatment With Kuvan®
Early Responders
|
64.4 Percentage of participants
Interval 50.9 to 76.4
|
|
Percentage of Early-, Late-, Partial-Responders and Non-responders to Treatment With Kuvan®
Late Responders
|
10.2 Percentage of participants
Interval 3.8 to 20.8
|
|
Percentage of Early-, Late-, Partial-Responders and Non-responders to Treatment With Kuvan®
Partial Responders
|
25.4 Percentage of participants
Interval 15.0 to 38.4
|
|
Percentage of Early-, Late-, Partial-Responders and Non-responders to Treatment With Kuvan®
Non-responders
|
0 Percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline up to Day 28 +/- 1Population: FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.
The Phenylketonuria (PKU) is categorized as per phenotype into classical PKU: (blood Phe levels greater than \[\>\] 1200 micromole per liter \[mcmol/l\]), mild PKU (blood Phe levels 600 to 1200 mcmol/l), mild Hyperphenylalaninaemia (HPA) (blood Phe levels 300 to 600 mcmol/l).
Outcome measures
| Measure |
Kuvan®
n=55 Participants
Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
|
|---|---|
|
Percentage of Participants With Greater Than or Equal to (>=) 30 Percent, 20 to 30 Percent, 10 to 20 Percent and Less Than (<) 10 Percent Reduction in Blood Phe Levels According to Phenylketonuria (PKU) Phenotypes
Mild HPA: >= 30 percent (n=7)
|
57 Percentage of participants
|
|
Percentage of Participants With Greater Than or Equal to (>=) 30 Percent, 20 to 30 Percent, 10 to 20 Percent and Less Than (<) 10 Percent Reduction in Blood Phe Levels According to Phenylketonuria (PKU) Phenotypes
Mild HPA: 20 to 30 percent (n=7)
|
29 Percentage of participants
24.9
|
|
Percentage of Participants With Greater Than or Equal to (>=) 30 Percent, 20 to 30 Percent, 10 to 20 Percent and Less Than (<) 10 Percent Reduction in Blood Phe Levels According to Phenylketonuria (PKU) Phenotypes
Mild HPA: 10 to 20 percent (n=7)
|
0 Percentage of participants
25.4
|
|
Percentage of Participants With Greater Than or Equal to (>=) 30 Percent, 20 to 30 Percent, 10 to 20 Percent and Less Than (<) 10 Percent Reduction in Blood Phe Levels According to Phenylketonuria (PKU) Phenotypes
Mild HPA: < 10 percent (n=7)
|
14 Percentage of participants
33.4
|
|
Percentage of Participants With Greater Than or Equal to (>=) 30 Percent, 20 to 30 Percent, 10 to 20 Percent and Less Than (<) 10 Percent Reduction in Blood Phe Levels According to Phenylketonuria (PKU) Phenotypes
Mild PKU: >= 30 percent (n=26)
|
69 Percentage of participants
96.2
|
|
Percentage of Participants With Greater Than or Equal to (>=) 30 Percent, 20 to 30 Percent, 10 to 20 Percent and Less Than (<) 10 Percent Reduction in Blood Phe Levels According to Phenylketonuria (PKU) Phenotypes
Mild PKU: 20 to 30 percent (n=26)
|
8 Percentage of participants
64.9
|
|
Percentage of Participants With Greater Than or Equal to (>=) 30 Percent, 20 to 30 Percent, 10 to 20 Percent and Less Than (<) 10 Percent Reduction in Blood Phe Levels According to Phenylketonuria (PKU) Phenotypes
Mild PKU: 10 to 20 percent (n=26)
|
4 Percentage of participants
60.8
|
|
Percentage of Participants With Greater Than or Equal to (>=) 30 Percent, 20 to 30 Percent, 10 to 20 Percent and Less Than (<) 10 Percent Reduction in Blood Phe Levels According to Phenylketonuria (PKU) Phenotypes
Mild PKU: < 10 percent (n=26)
|
19 Percentage of participants
69.3
|
|
Percentage of Participants With Greater Than or Equal to (>=) 30 Percent, 20 to 30 Percent, 10 to 20 Percent and Less Than (<) 10 Percent Reduction in Blood Phe Levels According to Phenylketonuria (PKU) Phenotypes
Classical PKU: >= 30 percent (n=22)
|
45 Percentage of participants
83.8
|
|
Percentage of Participants With Greater Than or Equal to (>=) 30 Percent, 20 to 30 Percent, 10 to 20 Percent and Less Than (<) 10 Percent Reduction in Blood Phe Levels According to Phenylketonuria (PKU) Phenotypes
Classical PKU: 20 to 30 percent (n=22)
|
0 Percentage of participants
|
|
Percentage of Participants With Greater Than or Equal to (>=) 30 Percent, 20 to 30 Percent, 10 to 20 Percent and Less Than (<) 10 Percent Reduction in Blood Phe Levels According to Phenylketonuria (PKU) Phenotypes
Classical PKU: 10 to 20 percent (n=22)
|
23 Percentage of participants
|
|
Percentage of Participants With Greater Than or Equal to (>=) 30 Percent, 20 to 30 Percent, 10 to 20 Percent and Less Than (<) 10 Percent Reduction in Blood Phe Levels According to Phenylketonuria (PKU) Phenotypes
Classical PKU: < 10 percent (n=22)
|
32 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 28 +/- 1Population: FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.
The PKU is categorized as per phenotype into classical PKU: (blood Phe levels \> 1200 mcmol/l), mild PKU (blood Phe levels 600 to 1200 mcmol/l), mild HPA (blood Phe levels 300 to 600 mcmol/l). Early responders defined as percentage of participants with at least 30 percent reduction in Phe levels within the first seven days of treatment. Late responders defined as percentage of participants with less than 30 percent reduction in Phe levels within first seven days of treatment, but at least 30 percent reduction in Phe levels within 28 +/- 1 days of treatment. Partial responders defined as percentage of participants with Phe levels reduction between 10 and 30 percent at any blood measurement within the 28 +/- 1 days of treatment.
Outcome measures
| Measure |
Kuvan®
n=56 Participants
Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
|
|---|---|
|
Percentage of Early-, Late- and Partial-Responders According to Phenotype
Mild HPA: Early Responders (n=7)
|
86 Percentage of participants
|
|
Percentage of Early-, Late- and Partial-Responders According to Phenotype
Mild HPA: Late Responders (n=7)
|
0 Percentage of participants
|
|
Percentage of Early-, Late- and Partial-Responders According to Phenotype
Mild HPA: Partial Responders (n=7)
|
14 Percentage of participants
|
|
Percentage of Early-, Late- and Partial-Responders According to Phenotype
Mild PKU: Early Responders (n=26)
|
85 Percentage of participants
|
|
Percentage of Early-, Late- and Partial-Responders According to Phenotype
Mild PKU: Late Responders (n=26)
|
4 Percentage of participants
|
|
Percentage of Early-, Late- and Partial-Responders According to Phenotype
Mild PKU: Partial Responders (n=26)
|
12 Percentage of participants
|
|
Percentage of Early-, Late- and Partial-Responders According to Phenotype
Classical PKU: Early Responders (n=23)
|
39 Percentage of participants
|
|
Percentage of Early-, Late- and Partial-Responders According to Phenotype
Classical PKU: Late Responders (n=23)
|
17 Percentage of participants
|
|
Percentage of Early-, Late- and Partial-Responders According to Phenotype
Classical PKU: Partial Responders (n=23)
|
43 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 28Population: FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®. 'n' signifies number of participants who were evaluable for specified categories at different time points.
Phenylalanine-to-tyrosine ratio is the best indicator of dopamine availability in PKU. The change in blood phenylalanine-to-tyrosine ratio at Day 28 was calculated as blood phenylalanine-to-tyrosine ratio at Day 28 minus blood phenylalanine-to-tyrosine ratio at Baseline.
Outcome measures
| Measure |
Kuvan®
n=59 Participants
Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
|
|---|---|
|
Mean Change From Baseline in Blood Phenylalanine-to-tyrosine Ratio
Baseline (n=59)
|
10.978 Ratio
Standard Deviation 5.978
|
|
Mean Change From Baseline in Blood Phenylalanine-to-tyrosine Ratio
Change at Day 28 (n=58)
|
-2.136 Ratio
Standard Deviation 3.948
|
Adverse Events
Kuvan®
Serious events: 0 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Kuvan®
n=59 participants at risk
Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
|
|---|---|
|
Cardiac disorders
Dizziness
|
3.4%
2/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Ear and labyrinth disorders
Ear pain
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Eye disorders
Dry eye
|
3.4%
2/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Eye disorders
Eye pruritus
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.8%
4/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.2%
6/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.7%
14/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
3/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Flatulence
|
5.1%
3/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Gingival pruritus
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Nausea
|
23.7%
14/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
3.4%
2/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Tongue blistering
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Toothache
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
2/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Asthenia
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Chest pain
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Discomfort
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Fatigue
|
8.5%
5/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Influenza like illness
|
5.1%
3/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Listless
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Malaise
|
3.4%
2/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Pain
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Pyrexia
|
8.5%
5/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Gastroenteritis viral
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Influenza
|
3.4%
2/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Oral herpes
|
3.4%
2/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Pharyngitis
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Rhinitis
|
5.1%
3/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Sinusitis
|
3.4%
2/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.2%
6/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Urinary tract infection
|
3.4%
2/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Viral infection
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Fall
|
5.1%
3/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Injury
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Joint injury
|
3.4%
2/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Amino acid level decreased
|
35.6%
21/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
2/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
2/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Joint lock
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Dizziness
|
3.4%
2/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Headache
|
42.4%
25/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Migraine
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Irritability
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Somatoform disorder
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Renal and urinary disorders
Dysuria
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
6.8%
4/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Acute tonsillitis
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
2/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
18.6%
11/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.8%
4/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
3.4%
2/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.4%
2/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Migraine
|
1.7%
1/59 • Baseline up to Day 42 +/- 3
An adverse event is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER