Trial Outcomes & Findings for Adherence to PTH(1-84) Treatment (FP-002-IM) (NCT NCT00478569)

Last Updated: 2014-05-28

Results Overview

A participant was defined as "permanently discontinued" if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards.

Recruitment status

COMPLETED

Target enrollment

1179 participants

Primary outcome timeframe

6 months

Results posted on

2014-05-28

Participant Flow

Participants took part in the study at 120 investigative sites in Austria, Denmark, Germany, Greece, Ireland, the Netherlands, Spain, and the United Kingdom from 1 April 2007 to 6 March 2013.

Participants with a diagnosis of osteoporosis and prescribed parathyroid hormone (PTH)(1-84) in a normal clinical setting were enrolled in this non-interventional study for 24 months observation. 1179 participants were enrolled however for 9 patients the data was missing.

Participant milestones

Participant milestones
Measure	Parathyroid Hormone (PTH) (1-84) PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
Overall Study STARTED	1170
Overall Study COMPLETED	761
Overall Study NOT COMPLETED	409

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adherence to PTH(1-84) Treatment (FP-002-IM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parathyroid Hormone (PTH) (1-84) n=1170 Participants PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
Age, Continuous	72.3 years STANDARD_DEVIATION 9.05 • n=99 Participants
Sex/Gender, Customized Male	19 participants n=99 Participants
Sex/Gender, Customized Female	1149 participants n=99 Participants
Sex/Gender, Customized Missing	2 participants n=99 Participants
Race/Ethnicity, Customized Caucasian	1165 participants n=99 Participants
Race/Ethnicity, Customized Asian	1 participants n=99 Participants
Race/Ethnicity, Customized African	1 participants n=99 Participants
Race/Ethnicity, Customized Other	1 participants n=99 Participants
Race/Ethnicity, Customized Missing	2 participants n=99 Participants
Region of Enrollment Austria	158 participants n=99 Participants
Region of Enrollment Denmark	79 participants n=99 Participants
Region of Enrollment Germany	246 participants n=99 Participants
Region of Enrollment Greece	300 participants n=99 Participants
Region of Enrollment Ireland	29 participants n=99 Participants
Region of Enrollment Netherlands	65 participants n=99 Participants
Region of Enrollment Spain	272 participants n=99 Participants
Region of Enrollment United Kingdom	21 participants n=99 Participants
Height	156.3 cm STANDARD_DEVIATION 7.98 • n=99 Participants
Weight	63.4 kg STANDARD_DEVIATION 12.25 • n=99 Participants
Body Mass Index (BMI)	25.9 kg/m^2 STANDARD_DEVIATION 4.59 • n=99 Participants
Age at Onset of Menopause	47.9 years STANDARD_DEVIATION 5.49 • n=99 Participants
Age at Onset of Menopause by Category ≤ 45 years	283 participants n=99 Participants
Age at Onset of Menopause by Category > 45 years	749 participants n=99 Participants
Age at Onset of Menopause by Category Missing	116 participants n=99 Participants
Type of Menopause Surgical	137 participants n=99 Participants
Type of Menopause Natural	966 participants n=99 Participants
Type of Menopause Other	25 participants n=99 Participants
Type of Menopause Missing	20 participants n=99 Participants
Calcium and/or Vitamin D Supplement Yes	1046 participants n=99 Participants
Calcium and/or Vitamin D Supplement No	122 participants n=99 Participants
Calcium and/or Vitamin D Supplement Missing	2 participants n=99 Participants
Time Since Starting PTH(1-84)	8.1 days STANDARD_DEVIATION 15.52 • n=99 Participants
PTH (1-84) Dosing Frequency Once Daily	1162 participants n=99 Participants
PTH (1-84) Dosing Frequency Every Other Day	6 participants n=99 Participants
PTH (1-84) Dosing Frequency Missing	2 participants n=99 Participants
Family History of Osteoporosis Yes	223 participants n=99 Participants
Family History of Osteoporosis No	896 participants n=99 Participants
Family History of Osteoporosis Unknown	1 participants n=99 Participants
Family History of Osteoporosis Missing	50 participants n=99 Participants
Alcohol Consumption Never	709 participants n=99 Participants
Alcohol Consumption Occasionally	385 participants n=99 Participants
Alcohol Consumption Daily	50 participants n=99 Participants
Alcohol Consumption Missing	26 participants n=99 Participants
Current Smoker Yes	111 participants n=99 Participants
Current Smoker No	1057 participants n=99 Participants
Current Smoker Missing	2 participants n=99 Participants
Past Smoker Yes	159 participants n=99 Participants
Past Smoker No	1009 participants n=99 Participants
Past Smoker Missing	2 participants n=99 Participants
Glucocorticosteroid Use Yes	129 participants n=99 Participants
Glucocorticosteroid Use No	1038 participants n=99 Participants
Glucocorticosteroid Use Missing	3 participants n=99 Participants
Total Hip Bone Mineral Density (BMD)	0.680 g/cm^2 STANDARD_DEVIATION 0.1239 • n=99 Participants
Total Hip T-score	-2.46 units on a scale STANDARD_DEVIATION 0.965 • n=99 Participants
Spine Bone Mineral Density (BMD)	0.763 g/cm^2 STANDARD_DEVIATION 0.1480 • n=99 Participants
Spine T-score	-3.10 units on a scale STANDARD_DEVIATION 1.130 • n=99 Participants
Number of Participants With at Least One Fracture	904 participants n=99 Participants
Was Patient/relative/helper instructed in PTH(1-84) (self) injection technique? Yes	1167 participants n=99 Participants
Was Patient/relative/helper instructed in PTH(1-84) (self) injection technique? No	1 participants n=99 Participants
Was Patient/relative/helper instructed in PTH(1-84) (self) injection technique? Missing	2 participants n=99 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All enrolled participants

A participant was defined as "permanently discontinued" if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards.

Outcome measures

Outcome measures
Measure	Parathyroid Hormone (PTH) (1-84) n=1170 Participants PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.	12 Months	18 Months	24 Months	24 Months
Number of Participants Who Discontinued Before 6 Months of Treatment	181 participants	—	—	—	—

SECONDARY outcome

Timeframe: From enrollment to 3, 12, 18, and 24 months

Population: All enrolled participants

A participant was defined as "permanently discontinued" if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards. A participant was defined as "temporarily discontinued" if treatment with PTH(1-84) was not ongoing at the time point but was then ongoing at a future time point. This was the case when a participant or investigator wanted to pause the treatment for a length of time (e.g. because of an adverse event or interruption). Therefore, a participant was defined as still "ongoing" during the trial if treatment with PTH(1-84) had not been permanently or temporarily discontinued at that time point. A participant was only defined as "missing" or "unknown" if they attended the relevant visit and there was no result or "unknown" was entered as the result. Results for months 3, 12, 18 and 24 are cumulative data up until that time point.

Outcome measures

Outcome measures
Measure	Parathyroid Hormone (PTH) (1-84) n=1170 Participants PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.	12 Months n=1170 Participants	18 Months n=1170 Participants	24 Months n=1170 Participants	24 Months
Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment Permanently discontinued	75 participants	198 participants	284 participants	525 participants	—
Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment Unknown	0 participants	0 participants	0 participants	0 participants	—
Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment Temporarily discontinued	6 participants	8 participants	2 participants	2 participants	—
Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment Ongoing	898 participants	847 participants	709 participants	375 participants	—
Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment Missing	191 participants	117 participants	175 participants	268 participants	—

SECONDARY outcome

Timeframe: 24 months

Population: Participants for whom data were available

Duration of treatment was defined as the last known date that PTH(1-84) was taken minus the first date that PTH(1-84) was taken plus one. In the calculation of duration, no adjustment was made for the prescribed dose frequency or for periods of temporary discontinuation due to adverse drug reactions (ADRs) or temporary patient suspension of treatment.

Outcome measures

Outcome measures
Measure	Parathyroid Hormone (PTH) (1-84) n=1156 Participants PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.	12 Months	18 Months	24 Months	24 Months
Duration of Treatment	17.7 months Interval 0.0 to 35.0	—	—	—	—

SECONDARY outcome

Timeframe: From enrollment to 3, 6, 12, 18, and 24 months

A participant was defined as compliant if the participant took the treatment as prescribed by the Physician, i.e. complied with the Physician's advice and followed the treatment regimen prescribed. A participant whose dose frequency and treatment length were changed during treatment, e.g. in response to a raised serum calcium level, was regarded as fully compliant if the revised treatment regimen was adhered to. Data on compliance were obtained at each visit and relate to the period since the previous recorded visit.

Outcome measures

Outcome measures
Measure	Parathyroid Hormone (PTH) (1-84) n=1170 Participants PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.	12 Months n=1170 Participants	18 Months n=1170 Participants	24 Months n=1170 Participants	24 Months n=1170 Participants
Treatment Compliance by Visit Compliant	875 participants	845 participants	800 participants	721 participants	558 participants
Treatment Compliance by Visit Non-compliant	105 participants	80 participants	95 participants	89 participants	93 participants
Treatment Compliance by Visit Missing	190 participants	245 participants	275 participants	360 participants	519 participants

Adverse Events

Parathyroid Hormone (PTH) (1-84)

Serious events: 10 serious events

Other events: 276 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Parathyroid Hormone (PTH) (1-84) n=1170 participants at risk PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
Gastrointestinal disorders Abdominal pain	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Gastrointestinal disorders Diarrhoea	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Gastrointestinal disorders Nausea	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
General disorders Pain	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Injury, poisoning and procedural complications Fall	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Investigations Blood calcium increased	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Investigations Weight decreased	0.17% 2/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Metabolism and nutrition disorders Hypercalcaemia	0.34% 4/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Nervous system disorders Dizziness	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Nervous system disorders Headache	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Nervous system disorders Tremor	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.

Other adverse events

Other adverse events
Measure	Parathyroid Hormone (PTH) (1-84) n=1170 participants at risk PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
Cardiac disorders Palpitations	0.43% 5/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Cardiac disorders Tachycardia	0.43% 5/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Ear and labyrinth disorders Motion sickness	0.26% 3/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Ear and labyrinth disorders Tinnitus	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Ear and labyrinth disorders Vertigo	0.43% 5/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Endocrine disorders Hyperparathyroidism	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Eye disorders Panophthalmitis	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Eye disorders Visual impairment	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Gastrointestinal disorders Abdominal discomfort	0.26% 3/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Gastrointestinal disorders Abdominal pain	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Gastrointestinal disorders Abdominal pain upper	0.34% 4/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Gastrointestinal disorders Constipation	0.34% 4/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Gastrointestinal disorders Diarrhoea	0.43% 5/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Gastrointestinal disorders Dyspepsia	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Gastrointestinal disorders Nausea	5.6% 66/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Gastrointestinal disorders Reflux gastritis	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Gastrointestinal disorders Vomiting	1.4% 16/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
General disorders Asthenia	0.34% 4/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
General disorders Chest discomfort	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
General disorders Chills	0.17% 2/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
General disorders Discomfort	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
General disorders Fatigue	0.51% 6/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
General disorders Feeling abnormal	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
General disorders Gait disturbance	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
General disorders Influenza like illness	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
General disorders Injection site haematoma	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
General disorders Injection site reaction	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
General disorders Malaise	0.77% 9/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
General disorders Pain	0.34% 4/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
General disorders Pyrexia	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Infections and infestations Influenza	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Infections and infestations Nasopharyngitis	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Investigations Blood alkaline phosphatase increased	0.26% 3/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Investigations Blood calcium abnormal	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Investigations Blood pressure systolic increased	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Investigations Weight decreased	0.17% 2/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Investigations Weight increased	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Metabolism and nutrition disorders Anorexia	0.26% 3/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Metabolism and nutrition disorders Decreased appetite	0.43% 5/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Metabolism and nutrition disorders Hypercalcaemia	10.5% 123/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Metabolism and nutrition disorders Hypocalcaemia	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Metabolism and nutrition disorders Hypocalcemia	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.51% 6/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Musculoskeletal and connective tissue disorders Arthropathy	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Musculoskeletal and connective tissue disorders Back pain	0.51% 6/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.17% 2/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Musculoskeletal and connective tissue disorders Mobility decreased	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.51% 6/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.26% 3/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.26% 3/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.17% 2/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Nervous system disorders Balance disorder	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Nervous system disorders Burning sensation mucosal	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Nervous system disorders Dizziness	1.7% 20/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Nervous system disorders Dysgeusia	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Nervous system disorders Encephalopathy	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Nervous system disorders Headache	2.3% 27/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Nervous system disorders Paraesthesia	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Nervous system disorders Transient ischaemic attack	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Nervous system disorders Tremor	0.17% 2/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Psychiatric disorders Depression	0.26% 3/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Psychiatric disorders Restlessness	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Psychiatric disorders Sleep disorder	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Renal and urinary disorders Hypercalciuria	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Renal and urinary disorders Nephrolithiasis	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Renal and urinary disorders Nocturia	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Renal and urinary disorders Pollakiuria	0.17% 2/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Reproductive system and breast disorders Pelvic pain	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.17% 2/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Skin and subcutaneous tissue disorders Alopecia	0.68% 8/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Skin and subcutaneous tissue disorders Lipoatrophy	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Skin and subcutaneous tissue disorders Petechiae	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Skin and subcutaneous tissue disorders Pruritus	0.17% 2/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Skin and subcutaneous tissue disorders Pruritus generalised	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Skin and subcutaneous tissue disorders Rash	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Skin and subcutaneous tissue disorders Rash generalised	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Skin and subcutaneous tissue disorders Rash papulosquamous	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Vascular disorders Circulatory collapse	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Vascular disorders Haematoma	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Vascular disorders Hot flush	0.34% 4/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Vascular disorders Hypertension	0.17% 2/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Vascular disorders Hypertensive crisis	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
Vascular disorders Hypotension	0.09% 1/1170 • 24 months At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.

Additional Information

Medical Director

Takeda

Phone: 800-778-2860

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any study related publication will be multi-center or single-center publications. All proposed site publications and presentations will be submitted to (sponsor) NPS Pharmaceuticals for review in advance of publication.
Publication restrictions are in place

Restriction type: OTHER