Trial Outcomes & Findings for Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome (NCT NCT00933686)
NCT ID: NCT00933686
Last Updated: 2013-08-02
Results Overview
The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the American College of Rheumatology (ACR) criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
113 participants
Primary outcome timeframe
Month 6
Results posted on
2013-08-02
Participant Flow
123 subjects were enrolled of whom 113 subjects were randomised and treated.
Participant milestones
| Measure |
Saizen®
Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
|
Placebo + Saizen®
Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
58
|
|
Overall Study
COMPLETED
|
45
|
47
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
Reasons for withdrawal
| Measure |
Saizen®
Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
|
Placebo + Saizen®
Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Failure to show up at endpoint visits
|
0
|
2
|
Baseline Characteristics
Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome
Baseline characteristics by cohort
| Measure |
Saizen®
n=55 Participants
Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
|
Placebo + Saizen®
n=58 Participants
Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
49.9 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
50.3 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
50.1 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: Intention-to-treat (ITT) population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure.
The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the American College of Rheumatology (ACR) criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis.
Outcome measures
| Measure |
Saizen®
n=51 Participants
Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
|
Placebo + Saizen®
n=50 Participants
Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
|
|---|---|---|
|
Percentage of Participants With Less Than 11 Tender Points at Month 6
|
20 Percentage of participants
|
22 Percentage of participants
|
PRIMARY outcome
Timeframe: Month 12Population: ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure.
The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the ACR criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis.
Outcome measures
| Measure |
Saizen®
n=45 Participants
Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
|
Placebo + Saizen®
n=47 Participants
Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
|
|---|---|---|
|
Percentage of Participants With Less Than 11 Tender Points at Month 12
|
53 Percentage of participants
|
34 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 3, 6, 7, 9 and 12Population: ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.
Fibromyalgia Impact Questionnaire (FIQ) is a 10-item questionnaire that measures physical impairment, well-being, missed work, pain, fatigue, rest, stiffness, anxiety, and depression. Score ranges from 0 (best result - very well) to 100 (worst result - awful).
Outcome measures
| Measure |
Saizen®
n=54 Participants
Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
|
Placebo + Saizen®
n=57 Participants
Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
|
|---|---|---|
|
Fibromyalgia Impact Questionnaire (FIQ) Total Score
Baseline (n=54, 57)
|
85.7 Units on a scale
Standard Deviation 2.3
|
86.0 Units on a scale
Standard Deviation 1.8
|
|
Fibromyalgia Impact Questionnaire (FIQ) Total Score
Month 1 (n=52, 54)
|
74.6 Units on a scale
Standard Deviation 3.6
|
73.3 Units on a scale
Standard Deviation 4.7
|
|
Fibromyalgia Impact Questionnaire (FIQ) Total Score
Month 3 (n=52, 54)
|
72.1 Units on a scale
Standard Deviation 4.4
|
66.4 Units on a scale
Standard Deviation 5.1
|
|
Fibromyalgia Impact Questionnaire (FIQ) Total Score
Month 6 (n=51, 50)
|
65.8 Units on a scale
Standard Deviation 4.8
|
68.4 Units on a scale
Standard Deviation 5.3
|
|
Fibromyalgia Impact Questionnaire (FIQ) Total Score
Month 7 (n=51, 50)
|
59.2 Units on a scale
Standard Deviation 5.5
|
65.8 Units on a scale
Standard Deviation 5.7
|
|
Fibromyalgia Impact Questionnaire (FIQ) Total Score
Month 9 (n=51, 50)
|
58.2 Units on a scale
Standard Deviation 6.4
|
65.1 Units on a scale
Standard Deviation 5.7
|
|
Fibromyalgia Impact Questionnaire (FIQ) Total Score
Month 12 (n=45, 47)
|
52.5 Units on a scale
Standard Deviation 6.5
|
64.7 Units on a scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 3, 6, 7, 9 and 12Population: ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.
Visual Analog Scale (VAS) is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain.
Outcome measures
| Measure |
Saizen®
n=54 Participants
Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
|
Placebo + Saizen®
n=57 Participants
Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
|
|---|---|---|
|
Visual Analog Scale (VAS) Total Score
Baseline (n=54, 57)
|
73.3 mm
Standard Deviation 3.4
|
74.3 mm
Standard Deviation 3.1
|
|
Visual Analog Scale (VAS) Total Score
Month 1 (n=52, 54)
|
65.1 mm
Standard Deviation 4.2
|
68.0 mm
Standard Deviation 5.7
|
|
Visual Analog Scale (VAS) Total Score
Month 3 (n=52, 54)
|
63.7 mm
Standard Deviation 5.6
|
58.4 mm
Standard Deviation 5.8
|
|
Visual Analog Scale (VAS) Total Score
Month 6 (n=51, 50)
|
57.6 mm
Standard Deviation 5.7
|
60.4 mm
Standard Deviation 6.6
|
|
Visual Analog Scale (VAS) Total Score
Month 7 (n=51, 50)
|
54.6 mm
Standard Deviation 5.2
|
56.1 mm
Standard Deviation 6.2
|
|
Visual Analog Scale (VAS) Total Score
Month 9 (n=51, 50)
|
51.2 mm
Standard Deviation 6.7
|
60.3 mm
Standard Deviation 6.3
|
|
Visual Analog Scale (VAS) Total Score
Month 12 (n=45, 47)
|
45.0 mm
Standard Deviation 6.9
|
60.6 mm
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 3, 6, 7, 9 and 12Population: ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.
EuroQol 5-Dimensions (EQ-5D) questionnaire is a measure of health status and quality of life (QoL). The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Score range for each item is 0 to 3, with 3 being the most severe. Total score range is 0 to 15. Lower scores represent a better QoL.
Outcome measures
| Measure |
Saizen®
n=54 Participants
Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
|
Placebo + Saizen®
n=57 Participants
Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
|
|---|---|---|
|
EuroQol 5-Dimensions (EQ-5D) Total Score
Baseline (n=54, 57)
|
11.07 Units on a scale
Standard Deviation 0.44
|
11.24 Units on a scale
Standard Deviation 0.42
|
|
EuroQol 5-Dimensions (EQ-5D) Total Score
Month 1 (n=52, 54)
|
10.46 Units on a scale
Standard Deviation 0.45
|
10.45 Units on a scale
Standard Deviation 0.42
|
|
EuroQol 5-Dimensions (EQ-5D) Total Score
Month 3 (n=52, 54)
|
10.13 Units on a scale
Standard Deviation 0.45
|
10.06 Units on a scale
Standard Deviation 0.55
|
|
EuroQol 5-Dimensions (EQ-5D) Total Score
Month 6 (n=51, 50)
|
10.00 Units on a scale
Standard Deviation 0.48
|
10.16 Units on a scale
Standard Deviation 0.56
|
|
EuroQol 5-Dimensions (EQ-5D) Total Score
Month 7 (n=51, 50)
|
9.63 Units on a scale
Standard Deviation 0.49
|
9.77 Units on a scale
Standard Deviation 0.54
|
|
EuroQol 5-Dimensions (EQ-5D) Total Score
Month 9 (n=51, 50)
|
9.49 Units on a scale
Standard Deviation 0.60
|
9.80 Units on a scale
Standard Deviation 0.50
|
|
EuroQol 5-Dimensions (EQ-5D) Total Score
Month 12 (n=45, 47)
|
9.09 Units on a scale
Standard Deviation 0.64
|
9.94 Units on a scale
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and 12Population: ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.
Multidimensional Assessment of Fatigue (MAF) consists of 16 questions. The score range for first 14 questions is between 0 and 10 for each question while for the last two questions it is 0 and 4 for each question. Total score range for first 14 questions is 0 to 100 and for last two questions is 0 to 8. Lower scores on the each represent the better participant's condition, whereas, higher scores indicate worsening condition.
Outcome measures
| Measure |
Saizen®
n=54 Participants
Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
|
Placebo + Saizen®
n=57 Participants
Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
|
|---|---|---|
|
Multidimensional Assessment of Fatigue (MAF) Total Score
1 to 14 questions: Baseline (n=54, 57)
|
90 Units on a scale
|
83 Units on a scale
|
|
Multidimensional Assessment of Fatigue (MAF) Total Score
1 to 14 questions: Month 6 (n=51, 50)
|
85 Units on a scale
|
78 Units on a scale
|
|
Multidimensional Assessment of Fatigue (MAF) Total Score
1 to 14 questions: Month 12 (n=45, 47)
|
73 Units on a scale
|
78 Units on a scale
|
|
Multidimensional Assessment of Fatigue (MAF) Total Score
15 and 16 question: Baseline (n=54, 57)
|
7 Units on a scale
|
7 Units on a scale
|
|
Multidimensional Assessment of Fatigue (MAF) Total Score
15 and 16 question: Month 6 (n=51, 50)
|
6 Units on a scale
|
6 Units on a scale
|
|
Multidimensional Assessment of Fatigue (MAF) Total Score
15 and 16 question: Month 12 (n=45, 47)
|
5 Units on a scale
|
6 Units on a scale
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and 12Population: ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.
Quality of Life Assessment of GH Deficiency in Adults (QoL AGHDA) questionnaire consists of 25 items that evoke yes or no answers. A score of 1 is given to each item affirmed and these are summed to give the total score. The maximum score is 25, which represents a poor quality of life. The minimum score is 0, which represents a good quality of life. Each question has to be answered with a NO/YES and for each YES, one point is added. The more YES, the higher the score and the worse. Decrease in the positive responses is an index of improvement. So, when the percentage of positive responses on the scale decreases, it is considered a response rate.
Outcome measures
| Measure |
Saizen®
n=54 Participants
Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
|
Placebo + Saizen®
n=57 Participants
Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
|
|---|---|---|
|
Percentage of Participants With Positive Response on Quality of Life Assessment of Growth Hormone [GH] Deficiency in Adults (QoL AGHDA) Scale
Baseline (n=54, 57)
|
73 Percentage of participants
|
72 Percentage of participants
|
|
Percentage of Participants With Positive Response on Quality of Life Assessment of Growth Hormone [GH] Deficiency in Adults (QoL AGHDA) Scale
Month 6 (n=51, 50)
|
70 Percentage of participants
|
69 Percentage of participants
|
|
Percentage of Participants With Positive Response on Quality of Life Assessment of Growth Hormone [GH] Deficiency in Adults (QoL AGHDA) Scale
Month 12 (n=45, 47)
|
59 Percentage of participants
|
70 Percentage of participants
|
Adverse Events
Saizen®
Serious events: 4 serious events
Other events: 45 other events
Deaths: 0 deaths
Placebo + Saizen®
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Saizen®
n=55 participants at risk
Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
|
Placebo + Saizen®
n=58 participants at risk
Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Nervous system disorders
Sleep apnoea syndrome
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Immune system disorders
Food allergy
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
Other adverse events
| Measure |
Saizen®
n=55 participants at risk
Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
|
Placebo + Saizen®
n=58 participants at risk
Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
3.6%
2/55 • Baseline up to Month 12
|
3.4%
2/58 • Baseline up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Acute sinusitis
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/55 • Baseline up to Month 12
|
6.9%
4/58 • Baseline up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
0.00%
0/55 • Baseline up to Month 12
|
3.4%
2/58 • Baseline up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/55 • Baseline up to Month 12
|
3.4%
2/58 • Baseline up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.00%
0/55 • Baseline up to Month 12
|
3.4%
2/58 • Baseline up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillitis
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.5%
3/55 • Baseline up to Month 12
|
3.4%
2/58 • Baseline up to Month 12
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Skin and subcutaneous tissue disorders
Furuncle
|
0.00%
0/55 • Baseline up to Month 12
|
3.4%
2/58 • Baseline up to Month 12
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Social circumstances
Impaired work ability
|
9.1%
5/55 • Baseline up to Month 12
|
12.1%
7/58 • Baseline up to Month 12
|
|
Social circumstances
Wheelchair user
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Vascular disorders
Hypertension
|
7.3%
4/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Vascular disorders
Hot flush
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Vascular disorders
Orthostatic hypotension
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/55 • Baseline up to Month 12
|
8.6%
5/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.00%
0/55 • Baseline up to Month 12
|
8.6%
5/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/55 • Baseline up to Month 12
|
5.2%
3/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/55 • Baseline up to Month 12
|
5.2%
3/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Epicondylitis
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Ganglion
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Muscle rupture
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Wrist deformity
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cyst
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polyp colorectal
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Nervous system disorders
Headache
|
38.2%
21/55 • Baseline up to Month 12
|
22.4%
13/58 • Baseline up to Month 12
|
|
Nervous system disorders
Paraesthesia
|
23.6%
13/55 • Baseline up to Month 12
|
10.3%
6/58 • Baseline up to Month 12
|
|
Nervous system disorders
Insomnia
|
16.4%
9/55 • Baseline up to Month 12
|
3.4%
2/58 • Baseline up to Month 12
|
|
Nervous system disorders
Carpal tunnel syndrome
|
14.5%
8/55 • Baseline up to Month 12
|
12.1%
7/58 • Baseline up to Month 12
|
|
Nervous system disorders
Somnolence
|
3.6%
2/55 • Baseline up to Month 12
|
6.9%
4/58 • Baseline up to Month 12
|
|
Nervous system disorders
Sciatica
|
3.6%
2/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Nervous system disorders
Syncope
|
0.00%
0/55 • Baseline up to Month 12
|
10.3%
6/58 • Baseline up to Month 12
|
|
Nervous system disorders
Migraine
|
0.00%
0/55 • Baseline up to Month 12
|
5.2%
3/58 • Baseline up to Month 12
|
|
Nervous system disorders
Tremor
|
0.00%
0/55 • Baseline up to Month 12
|
3.4%
2/58 • Baseline up to Month 12
|
|
Nervous system disorders
Dysphemia
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Psychiatric disorders
Anxiety
|
9.1%
5/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Psychiatric disorders
Amnesia
|
5.5%
3/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Psychiatric disorders
Depression
|
3.6%
2/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Psychiatric disorders
Sleep talking
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Psychiatric disorders
Memory impairment
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Renal and urinary disorders
Urinary tract infection
|
12.7%
7/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Renal and urinary disorders
Cystitis
|
5.5%
3/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Reproductive system and breast disorders
Breast pain
|
3.6%
2/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/55 • Baseline up to Month 12
|
3.4%
2/58 • Baseline up to Month 12
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/55 • Baseline up to Month 12
|
13.8%
8/58 • Baseline up to Month 12
|
|
Ear and labyrinth disorders
Otitis media acute
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Ear and labyrinth disorders
Dizziness
|
0.00%
0/55 • Baseline up to Month 12
|
8.6%
5/58 • Baseline up to Month 12
|
|
Ear and labyrinth disorders
Ear infection
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/55 • Baseline up to Month 12
|
3.4%
2/58 • Baseline up to Month 12
|
|
Eye disorders
Vision blurred
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Eye disorders
Visual acuity reduced
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Nausea
|
9.1%
5/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Abdominal distension
|
7.3%
4/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Abdominal pain
|
5.5%
3/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Aptyalism
|
1.8%
1/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Reproductive system and breast disorders
Amenorrhoea
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Cheilitis
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Flatulence
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Hiatus hernia
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/55 • Baseline up to Month 12
|
12.1%
7/58 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/55 • Baseline up to Month 12
|
3.4%
2/58 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/55 • Baseline up to Month 12
|
3.4%
2/58 • Baseline up to Month 12
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/55 • Baseline up to Month 12
|
6.9%
4/58 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/55 • Baseline up to Month 12
|
3.4%
2/58 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Dysgeusia
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Acetonaemic vomiting
|
0.00%
0/55 • Baseline up to Month 12
|
3.4%
2/58 • Baseline up to Month 12
|
|
General disorders
Pain exacerbated
|
9.1%
5/55 • Baseline up to Month 12
|
8.6%
5/58 • Baseline up to Month 12
|
|
General disorders
Pain
|
3.6%
2/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
General disorders
Asthenia
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
General disorders
Fatigue
|
0.00%
0/55 • Baseline up to Month 12
|
8.6%
5/58 • Baseline up to Month 12
|
|
General disorders
Fall
|
0.00%
0/55 • Baseline up to Month 12
|
3.4%
2/58 • Baseline up to Month 12
|
|
General disorders
Malaise
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Hepatobiliary disorders
Transaminases increased
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Immune system disorders
Hypersensitivity
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Immune system disorders
Food allergy
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Infections and infestations
Vaginal candidiasis
|
7.3%
4/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Reproductive system and breast disorders
Hypertrophy breast
|
0.00%
0/55 • Baseline up to Month 12
|
3.4%
2/58 • Baseline up to Month 12
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/55 • Baseline up to Month 12
|
5.2%
3/58 • Baseline up to Month 12
|
|
Infections and infestations
Corneal infection
|
0.00%
0/55 • Baseline up to Month 12
|
3.4%
2/58 • Baseline up to Month 12
|
|
Infections and infestations
Localised infection
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Injury, poisoning and procedural complications
Injury asphyxiation
|
1.8%
1/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/55 • Baseline up to Month 12
|
5.2%
3/58 • Baseline up to Month 12
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/55 • Baseline up to Month 12
|
3.4%
2/58 • Baseline up to Month 12
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/55 • Baseline up to Month 12
|
1.7%
1/58 • Baseline up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
10.9%
6/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Investigations
Arthroscopy
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Investigations
Blood pressure systolic increased
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.5%
3/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.8%
1/55 • Baseline up to Month 12
|
5.2%
3/58 • Baseline up to Month 12
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/55 • Baseline up to Month 12
|
13.8%
8/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Oedema
|
30.9%
17/55 • Baseline up to Month 12
|
25.9%
15/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.9%
6/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
4/55 • Baseline up to Month 12
|
13.8%
8/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.3%
4/55 • Baseline up to Month 12
|
5.2%
3/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.5%
3/55 • Baseline up to Month 12
|
8.6%
5/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
5.5%
3/55 • Baseline up to Month 12
|
3.4%
2/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
1.8%
1/55 • Baseline up to Month 12
|
27.6%
16/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Humerus fracture
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Pelvic fracture
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Radius fracture
|
1.8%
1/55 • Baseline up to Month 12
|
0.00%
0/58 • Baseline up to Month 12
|
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