Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency

• Sponsor: OPKO IP Holdings II, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01651000
• Collaborator: (none)
• Enrollment: 213
• Location: 1
• Arms: 2
• Duration (Months): 21.9
• Patients Per Site Per Month: 9.7

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease; Hyperparathyroidism, Secondary; Vitamin D Deficiency	Drug: CTAP101 30 μg capsules; Other: Sugar pill to CTAP101 30 μg capsules	Phase 3

Detailed Description

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of CTAP101 Capsules administered for 26 weeks to treat SHPT in subjects ≥18 years of age with stage 3 or 4 CKD and vitamin D insufficiency. The study will be conducted at approximately 40 sites within the United States (US). Approximately 550 subjects will be screened to randomize approximately 210 eligible subjects, stratified by CKD stage (approximately 105 subjects in each stage) in a 2:1 ratio to receive either CTAP101 Capsules or matching placebo. An Interactive Voice Response System (IVRS) will provide study treatment group assignments using the computer-generated randomization code provided by the IVRS vendor. Subjects will receive an initial daily dose of 1 capsule (CTAP101 Capsules, 30 µg, or matching placebo) for the first 12 weeks. After l2 weeks (visit 8) and per pre-defined criteria, the dose may be increased in a blinded fashion by the IVRS with oversight by an independent medical monitor.

Study Design

• Study Type: Interventional
• Actual Enrollment: 213 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of CTAP101 Capsules to Treat Secondary Hyperparathyroidism in Subjects With Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CTAP101 30 μg capsules 1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.	Drug: CTAP101 30 μg capsules; CTAP101 30 μg capsule taken daily at bedtime.; Other Names: Calcifediol ; Other: Sugar pill to CTAP101 30 μg capsules; Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.; Other Names: Placebo
Placebo Comparator: Sugar pill to CTAP101 30 μg capsule 1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.	Other: Sugar pill to CTAP101 30 μg capsules; Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values [Approximately 6 months]

   Number of subjects in the intent to treat population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.

Secondary Outcome Measures

1. Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values [Approximately 6 months]

   Number of subjects in the per protocol population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.

2. Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D [Approximately 6 months]

   Subjects in the Intent to Treat Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/dL)

3. Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D [Approximately 6 months]

   Subjects in the Per Protocol Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/mL)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Urinary albumin excretion ≤ 3000 mcg/mg of creatinine

2. Stage 3 or 4 CKD

3. Plasma iPTH: ≥ 85 pg/mL and < 500 pg/mL

4. Serum Ca: ≥ 8.4 mg/dL and < 9.8 mg/dL

5. Serum P: ≥ 2.0 mg/dL and < 5.0 mg/dL

6. Serum 25-hydroxyvitamin D: ≥ 10 ng/mL and < 30 ng/mL.

7. Stable dose of Vitamin D therapy ≤ 1600 IU/day and receiving same dose for at least 2 months

Exclusion Criteria:

1. History of kidney transplant or parathyroidectomy

2. Spot urine calcium:creatinine ratio > 0.2 (>200 mg/g Cr)

3. Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event or hepatitis

4. Currently on dialysis

5. Use of pharmacological dose of ergocalciferol or cholecalciferol (≥ 50,000 IU mcg per month) during the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OPKO Renal	Bannockburn	Illinois	United States	60015

Sponsors and Collaborators

• OPKO IP Holdings II, Inc.

Investigators

• Study Director: Joel Melnick, MD, Opko Renal

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: OPKO IP Holdings II, Inc.
• ClinicalTrials.gov Identifier: NCT01651000
• Other Study ID Numbers: CTAP101-CL-3001
• First Posted: Jul 26, 2012
• Last Update Posted: Dec 18, 2019
• Last Verified: Dec 1, 2019

• Keywords provided by OPKO IP Holdings II, Inc.: Parathyroid Diseases; Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism, Secondary; Vitamin D; Hyperparathyroidism; Kidney Diseases; Kidney Failure; Renal Insufficiency, Chronic
• Additional relevant MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Vitamin D Deficiency; Hyperparathyroidism; Hyperparathyroidism, Secondary; Calcifediol

Study Results

Participant Flow

Recruitment Details	This multicenter study was conducted at 44 investigational sites within the US. Subjects were enrolled and treated from 07 September 2012 through 20 July 2014.
Pre-assignment Detail	Subjects were stratified by CKD stage and were randomized in a 2:1 ratio to receive a daily 30 μg oral dose of CTAP101 capsules (or matching placebo) for 12 weeks at bedtime. Subjects presenting on a regimen of bone metabolism therapy were to discontinue their prior treatment for at least 28 days' washout (except for bisphosphonates).

Arm/Group Title	Sugar Pill to CTAP101 30 μg Capsule	CTAP101 30 μg Capsules
Arm/Group Description	1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26. Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.	1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26. CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime. Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
Period Title: Overall Study
STARTED	72	141
Entered Extension Study	50	93
COMPLETED	62	113
NOT COMPLETED	10	28

Baseline Characteristics

Arm/Group Title	Sugar Pill to CTAP101 30 μg Capsule	CTAP101 30 μg Capsules	Total
Arm/Group Description	1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26. Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.	1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26. CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime. Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.	Total of all reporting groups
Overall Participants	72	141	213
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.4 (12.74)	65.1 (10.33)	64.9 (11.18)
Sex: Female, Male (Count of Participants)
Female	33 45.8%	71 50.4%	104 48.8%
Male	39 54.2%	70 49.6%	109 51.2%
Region of Enrollment (participants) [Number]
United States	72 100%	141 100%	213 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values
Description	Number of subjects in the intent to treat population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.
Time Frame	Approximately 6 months

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	Sugar Pill to CTAP101 30 μg Capsule	CTAP101 30 μg Capsules
Arm/Group Description	1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26. Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.	1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26. CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime. Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
Measure Participants	72	141
Number [participants]	6 8.3%	46 32.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sugar Pill to CTAP101 30 μg Capsule, CTAP101 30 μg Capsules
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

2. Secondary Outcome

Title	Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values
Description	Number of subjects in the per protocol population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.
Time Frame	Approximately 6 months

Outcome Measure Data

Analysis Population Description

Per protocol

Arm/Group Title	Sugar Pill to CTAP101 30 μg Capsule	CTAP101 30 μg Capsules
Arm/Group Description	1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26. Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.	1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26. CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime. Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
Measure Participants	62	115
Number [participants]	5 6.9%	46 32.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sugar Pill to CTAP101 30 μg Capsule, CTAP101 30 μg Capsules
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

3. Secondary Outcome

Title	Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D
Description	Subjects in the Intent to Treat Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/dL)
Time Frame	Approximately 6 months

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	Sugar Pill to CTAP101 30 μg Capsule	CTAP101 30 μg Capsules
Arm/Group Description	1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26. Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.	1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26. CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime. Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
Measure Participants	72	141
Number [participants]	2 2.8%	113 80.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sugar Pill to CTAP101 30 μg Capsule, CTAP101 30 μg Capsules
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

4. Secondary Outcome

Title	Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D
Description	Subjects in the Per Protocol Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/mL)
Time Frame	Approximately 6 months

Outcome Measure Data

Analysis Population Description

Per protocol

Arm/Group Title	Sugar Pill to CTAP101 30 μg Capsule	CTAP101 30 μg Capsules
Arm/Group Description	1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26. Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.	1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26. CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime. Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
Measure Participants	62	115
Number [participants]	2 2.8%	110 78%

Adverse Events

Time Frame	6 months
Arm/Group Title	Sugar Pill to CTAP101 30 μg Capsule		CTAP101 30 μg Capsules
Arm/Group Description	1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26. Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.		1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26. CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime. Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
All Cause Mortality
	Sugar Pill to CTAP101 30 μg Capsule		CTAP101 30 μg Capsules
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Sugar Pill to CTAP101 30 μg Capsule		CTAP101 30 μg Capsules
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/72 (16.7%)		30/141 (21.3%)
Blood and lymphatic system disorders
Anaemia	1/72 (1.4%)	1	2/141 (1.4%)	2
Cardiac disorders
Angina pectoris	0/72 (0%)	0	1/141 (0.7%)	1
Arrhyhmia	1/72 (1.4%)	1	0/141 (0%)	0
Atrial fibrillation	0/72 (0%)	0	2/141 (1.4%)	2
Cardiac arrest	0/72 (0%)	0	1/141 (0.7%)	1
Cardiac failure congestive	0/72 (0%)	0	6/141 (4.3%)	6
Coronary artery disease	1/72 (1.4%)	1	0/141 (0%)	0
Gastrointestinal disorders
Colitis ischaemic	1/72 (1.4%)	1	0/141 (0%)	0
Gastrointestinal haemorrhage	0/72 (0%)	0	1/141 (0.7%)	1
Lower gastrointestinal haemorrhage	0/72 (0%)	0	1/141 (0.7%)	1
Stomatitis	0/72 (0%)	0	1/141 (0.7%)	1
General disorders
Asthenia	0/72 (0%)	0	1/141 (0.7%)	1
Chest pain	2/72 (2.8%)	2	2/141 (1.4%)	2
Oedema peripheral	0/72 (0%)	0	1/141 (0.7%)	1
Hepatobiliary disorders
Cholecystitis acute	0/72 (0%)	0	1/141 (0.7%)	1
Cholelithiasis	1/72 (1.4%)	1	0/141 (0%)	0
Infections and infestations
Cellulitis	1/72 (1.4%)	1	1/141 (0.7%)	1
Gastrointestinal viral infection	0/72 (0%)	0	1/141 (0.7%)	1
Pharyngitis	0/72 (0%)	0	1/141 (0.7%)	1
Pneumonia	0/72 (0%)	0	1/141 (0.7%)	1
Sepsis	1/72 (1.4%)	1	2/141 (1.4%)	2
Streptococcal bacteraemia	1/72 (1.4%)	1	0/141 (0%)	0
Urinary tract infection	1/72 (1.4%)	1	0/141 (0%)	0
Urosepsis	0/72 (0%)	0	2/141 (1.4%)	2
Wound infection	0/72 (0%)	0	1/141 (0.7%)	1
Injury, poisoning and procedural complications
Multiple fractures	0/72 (0%)	0	1/141 (0.7%)	1
Patella fracture	1/72 (1.4%)	1	0/141 (0%)	0
Ulna fracture	0/72 (0%)	0	1/141 (0.7%)	1
Investigations
Blood creatinine increased	0/72 (0%)	0	5/141 (3.5%)	5
Metabolism and nutrition disorders
Hyponatraemia	1/72 (1.4%)	1	0/141 (0%)	0
Hyperkalaemia	1/72 (1.4%)	1	0/141 (0%)	0
Fluid overload	0/72 (0%)	0	1/141 (0.7%)	1
Hypercalcaemia	0/72 (0%)	0	1/141 (0.7%)	1
Hypervolaemia	0/72 (0%)	0	1/141 (0.7%)	1
Hypovolaemia	1/72 (1.4%)	1	0/141 (0%)	0
Lactic acidosis	1/72 (1.4%)	1	0/141 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas	0/72 (0%)	0	1/141 (0.7%)	1
Endometrial cancer	0/72 (0%)	0	1/141 (0.7%)	1
Renal cell carcinoma	0/72 (0%)	0	1/141 (0.7%)	1
Nervous system disorders
Basal ganglia stroke	0/72 (0%)	0	1/141 (0.7%)	1
Cerebrovascular accident	1/72 (1.4%)	1	0/141 (0%)	0
Convulsion	0/72 (0%)	0	1/141 (0.7%)	1
Presyncope	1/72 (1.4%)	1	0/141 (0%)	0
Psychiatric disorders
Suicidal ideation	1/72 (1.4%)	1	0/141 (0%)	0
Renal and urinary disorders
Renal failure acute	1/72 (1.4%)	1	2/141 (1.4%)	2
Reproductive system and breast disorders
Menorrhagia	0/72 (0%)	0	1/141 (0.7%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/72 (0%)	0	1/141 (0.7%)	0
Asthma	0/72 (0%)	0	1/141 (0.7%)	1
Chronic obstructive pulmonary disease	0/72 (0%)	0	1/141 (0.7%)	1
Respiratory failure	1/72 (1.4%)	1	0/141 (0%)	0
Vascular disorders
Aortic intramural haematoma	1/72 (1.4%)	1	0/141 (0%)	0
Hypertension	0/72 (0%)	0	1/141 (0.7%)	1
Hypertensive crisis	0/72 (0%)	0	1/141 (0.7%)	1
Other (Not Including Serious) Adverse Events
	Sugar Pill to CTAP101 30 μg Capsule		CTAP101 30 μg Capsules
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	37/72 (51.4%)		44/141 (31.2%)
Gastrointestinal disorders
Diarrhoea	12/72 (16.7%)	12	6/141 (4.3%)	6
Nausea	6/72 (8.3%)	6	3/141 (2.1%)	3
Vomiting	5/72 (6.9%)	5	2/141 (1.4%)	2
General disorders
Oedema peripheral	5/72 (6.9%)	5	3/141 (2.1%)	3
Chest pain	4/72 (5.6%)	4	3/141 (2.1%)	3
Infections and infestations
Urinary tract infection	10/72 (13.9%)	10	7/141 (5%)	7
Upper respiratory tract infection	4/72 (5.6%)	4	4/141 (2.8%)	4
Metabolism and nutrition disorders
Hypoglycaemia	4/72 (5.6%)	4	4/141 (2.8%)	4
Hypokalaemia	4/72 (5.6%)	4	1/141 (0.7%)	1
Musculoskeletal and connective tissue disorders
Back pain	6/72 (8.3%)	6	6/141 (4.3%)	6
Arthralgia	6/72 (8.3%)	6	3/141 (2.1%)	3
Pain in extremity	4/72 (5.6%)	4	3/141 (2.1%)	3
Respiratory, thoracic and mediastinal disorders
Dyspnoea	4/72 (5.6%)	4	6/141 (4.3%)	6
Vascular disorders
Hypertension	5/72 (6.9%)	5	9/141 (6.4%)	9

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.