Trial Outcomes & Findings for Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency (NCT NCT03588884)
NCT ID: NCT03588884
Last Updated: 2022-12-09
Results Overview
This study is descriptive and no primary or secondary efficacy endpoints are defined.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
69 participants
Primary outcome timeframe
5 months
Results posted on
2022-12-09
Participant Flow
Participant milestones
| Measure |
CTAP101
CTAP101/Calcifediol Capsules 60 micrograms (mcg) once daily at bedtime, except on Days 1 and 29 when dosing will occur in the morning before breakfast
Calcifediol Oral Capsule: Capsule, daily
|
Immediate-release (IR) Calcifediol
Immediate-release (IR) calcifediol/266 micrograms (mcg) capsule before breakfast on the mornings of Day 1 and Day 29
Calcifediol Oral Product: Capsule, once a month
|
Cholecalciferol
Cholecalciferol/Capsules 300,000 International Units (IU) (high-dose) before breakfast on the mornings of Day 1 and Day 29
Cholecalciferol: Capsule, once a month
|
Paricalcitol
Paricalcitol/Capsules 1 mcg plus cholecalciferol capsules 800 IU (low-dose) once daily in the morning before breakfast, except on Days 1 and29 when dosing will occur before breakfast
Cholecalciferol: Capsule, once a month
Paricalcitol Oral Capsule: Capsule, daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
18
|
15
|
|
Overall Study
COMPLETED
|
18
|
15
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency
Baseline characteristics by cohort
| Measure |
CTAP101
n=18 Participants
CTAP101/Calcifediol Capsules 60 micrograms (mcg) once daily at bedtime, except on Days 1 and 29 when dosing will occur in the morning before breakfast
Calcifediol Oral Capsule: Capsule, daily
|
Immediate-release (IR) Calcifediol
n=18 Participants
Immediate-release (IR) calcifediol/266 micrograms (mcg) capsule before breakfast on the mornings of Day 1 and Day 29
Calcifediol Oral Product: Capsule, once a month
|
Cholecalciferol
n=18 Participants
Cholecalciferol/Capsules 300,000 International Units (IU) (high-dose) before breakfast on the mornings of Day 1 and Day 29
Cholecalciferol: Capsule, once a month
|
Paricalcitol
n=15 Participants
Paricalcitol/Capsules 1 mcg plus cholecalciferol capsules 800 IU (low-dose) once daily in the morning before breakfast, except on Days 1 and29 when dosing will occur before breakfast
Cholecalciferol: Capsule, once a month
Paricalcitol Oral Capsule: Capsule, daily
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67.1 Year
STANDARD_DEVIATION 10.7 • n=5 Participants
|
70.1 Year
STANDARD_DEVIATION 14.4 • n=7 Participants
|
67.9 Year
STANDARD_DEVIATION 9.8 • n=5 Participants
|
63.4 Year
STANDARD_DEVIATION 12.0 • n=4 Participants
|
67.3 Year
STANDARD_DEVIATION 11.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 5 monthsThis study is descriptive and no primary or secondary efficacy endpoints are defined.
Outcome measures
| Measure |
CTAP101
n=18 Participants
CTAP101/Calcifediol Capsules 60 micrograms (mcg) once daily at bedtime, except on Days 1 and 29 when dosing will occur in the morning before breakfast
Calcifediol Oral Capsule: Capsule, daily
|
Immediate-release (IR) Calcifediol
n=18 Participants
Immediate-release (IR) calcifediol/266 micrograms (mcg) capsule before breakfast on the mornings of Day 1 and Day 29
Calcifediol Oral Product: Capsule, once a month
|
Cholecalciferol
n=18 Participants
Cholecalciferol/Capsules 300,000 International Units (IU) (high-dose) before breakfast on the mornings of Day 1 and Day 29
Cholecalciferol: Capsule, once a month
|
Paricalcitol
n=15 Participants
Paricalcitol/Capsules 1 mcg plus cholecalciferol capsules 800 IU (low-dose) once daily in the morning before breakfast, except on Days 1 and29 when dosing will occur before breakfast
Cholecalciferol: Capsule, once a month
Paricalcitol Oral Capsule: Capsule, daily
|
|---|---|---|---|---|
|
Incidence and Severity of Treatment-Emergent Adverse Events (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Grade 2 Moderate
|
1 number of TEAE count
|
3 number of TEAE count
|
8 number of TEAE count
|
5 number of TEAE count
|
|
Incidence and Severity of Treatment-Emergent Adverse Events (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Grade 1 Mild
|
39 number of TEAE count
|
12 number of TEAE count
|
13 number of TEAE count
|
10 number of TEAE count
|
|
Incidence and Severity of Treatment-Emergent Adverse Events (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Grade 3 Severe
|
2 number of TEAE count
|
3 number of TEAE count
|
0 number of TEAE count
|
1 number of TEAE count
|
|
Incidence and Severity of Treatment-Emergent Adverse Events (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Grade Potentially Life Threatening
|
0 number of TEAE count
|
0 number of TEAE count
|
0 number of TEAE count
|
0 number of TEAE count
|
|
Incidence and Severity of Treatment-Emergent Adverse Events (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Grade 5 Fatal
|
0 number of TEAE count
|
0 number of TEAE count
|
0 number of TEAE count
|
0 number of TEAE count
|
Adverse Events
CTAP101
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Immediate-release (IR) Calcifediol
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Cholecalciferol
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Paricalcitol
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CTAP101
n=18 participants at risk
CTAP101/Calcifediol Capsules 60 micrograms (mcg) once daily at bedtime, except on Days 1 and 29 when dosing will occur in the morning before breakfast
Calcifediol Oral Capsule: Capsule, daily
|
Immediate-release (IR) Calcifediol
n=18 participants at risk
Immediate-release (IR) calcifediol/266 micrograms (mcg) capsule before breakfast on the mornings of Day 1 and Day 29
Calcifediol Oral Product: Capsule, once a month
|
Cholecalciferol
n=18 participants at risk
Cholecalciferol/Capsules 300,000 International Units (IU) (high-dose) before breakfast on the mornings of Day 1 and Day 29
Cholecalciferol: Capsule, once a month
|
Paricalcitol
n=15 participants at risk
Paricalcitol/Capsules 1 mcg plus cholecalciferol capsules 800 IU (low-dose) once daily in the morning before breakfast, except on Days 1 and29 when dosing will occur before breakfast
Cholecalciferol: Capsule, once a month
Paricalcitol Oral Capsule: Capsule, daily
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
6.7%
1/15 • 5 months
|
|
Nervous system disorders
Quadrantanopia
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
6.7%
1/15 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
6.7%
1/15 • 5 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Blister
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
Other adverse events
| Measure |
CTAP101
n=18 participants at risk
CTAP101/Calcifediol Capsules 60 micrograms (mcg) once daily at bedtime, except on Days 1 and 29 when dosing will occur in the morning before breakfast
Calcifediol Oral Capsule: Capsule, daily
|
Immediate-release (IR) Calcifediol
n=18 participants at risk
Immediate-release (IR) calcifediol/266 micrograms (mcg) capsule before breakfast on the mornings of Day 1 and Day 29
Calcifediol Oral Product: Capsule, once a month
|
Cholecalciferol
n=18 participants at risk
Cholecalciferol/Capsules 300,000 International Units (IU) (high-dose) before breakfast on the mornings of Day 1 and Day 29
Cholecalciferol: Capsule, once a month
|
Paricalcitol
n=15 participants at risk
Paricalcitol/Capsules 1 mcg plus cholecalciferol capsules 800 IU (low-dose) once daily in the morning before breakfast, except on Days 1 and29 when dosing will occur before breakfast
Cholecalciferol: Capsule, once a month
Paricalcitol Oral Capsule: Capsule, daily
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
2/18 • 5 months
|
5.6%
1/18 • 5 months
|
5.6%
1/18 • 5 months
|
6.7%
1/15 • 5 months
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
6.7%
1/15 • 5 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
1/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
6.7%
1/15 • 5 months
|
|
Gastrointestinal disorders
Flatulence
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • 5 months
|
11.1%
2/18 • 5 months
|
0.00%
0/18 • 5 months
|
13.3%
2/15 • 5 months
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
6.7%
1/15 • 5 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Quadrantanopia
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
6.7%
1/15 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
6.7%
1/15 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
6.7%
1/15 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
6.7%
1/15 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
6.7%
1/15 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
General disorders
Asthenia
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
General disorders
Chills
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
General disorders
Fatigue
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
General disorders
Influenza like illness
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
General disorders
Peripheral swelling
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
General disorders
Tenderness
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
6.7%
1/15 • 5 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
11.1%
2/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
6.7%
1/15 • 5 months
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
6.7%
1/15 • 5 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
6.7%
1/15 • 5 months
|
|
Infections and infestations
Cystitis
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Eye disorders
Eye pain
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Investigations
Blood creatinine increased
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Reproductive system and breast disorders
Breast pain
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
5.6%
1/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.6%
1/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/18 • 5 months
|
0.00%
0/15 • 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Some institution and PI have the right to publish info 12 months after the study ended. For one PI that all Confidential Information must be held secret for a period of 5 years after end of the relevant Work Order.
- Publication restrictions are in place
Restriction type: OTHER