Trial Outcomes & Findings for Post Marketing Observational Study on Paricalcitol IV Administered to Venezuelan Patients (NCT NCT01758289)

NCT ID: NCT01758289

Last Updated: 2014-11-17

Results Overview

• Recruitment status: TERMINATED
• Target enrollment: 105 participants
• Primary outcome timeframe: Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)
• Results posted on: 2014-11-17

Participant Flow

Participant milestones

Measure	Paricalcitol IV Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol intravenous (IV) per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
Overall Study STARTED	105
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	53

Reasons for withdrawal

Measure	Paricalcitol IV Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol intravenous (IV) per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
Overall Study Premature Study Termination	44
Overall Study Adverse Event	9

Baseline Characteristics

Post Marketing Observational Study on Paricalcitol IV Administered to Venezuelan Patients

Baseline characteristics by cohort

Measure	Paricalcitol IV n=105 Participants Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
Age, Continuous	53.00 years STANDARD_DEVIATION 13.90 • n=5 Participants
Sex/Gender, Customized Female	37 participants n=5 Participants
Sex/Gender, Customized Male	67 participants n=5 Participants
Sex/Gender, Customized Not Reported	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)

Population: Participants with valid PTH values at Baseline and Final Study Visit.

Outcome measures

Measure	Paricalcitol IV n=50 Participants Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Paricalcitol IV: Week 12 Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Paricalcitol IV: Week 24 Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
Percentage of Participants Achieving at Least a 30% Reduction From Baseline in the Levels of Parathyroid Hormone (PTH) at the Final Study Visit	62 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)

Population: Participants with valid assessments at given time point.

Hypercalcemia was defined as a value of serum calcium (Ca) greater than or equal to 10.3 mg/dL.

Hyperphosphatemia was defined as a value of serum phosphorus (P) greater than or equal to 5.5 mg/dL.

Elevated Ca×P was defined as as greater or equal to 56.65 mg^2/dL^2, calculated as the result of multiplying the maximum values of calcium (10.3 mg/dL) and phosphorus (5.5 mg/dL).

Outcome measures

Measure	Paricalcitol IV n=105 Participants Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Paricalcitol IV: Week 12 n=70 Participants Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Paricalcitol IV: Week 24 n=50 Participants Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24 Hypercalcemia	1.90 percentage of participants	1.42 percentage of participants	14.00 percentage of participants
Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24 Hyperphosphatemia	28.57 percentage of participants	42.85 percentage of participants	38.00 percentage of participants
Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24 Elevations of (Ca x P)	15.23 percentage of participants	32.85 percentage of participants	20.00 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 12, Week 12 to Week 24

Population: All participants; n=participants with valid PTH values at given time point.

Participants who achieved PTH Levels < 300 pg/mL between the first and third study visit (Baseline to Week 12) and the third and final study visit (Week 12 to Week 24).

Outcome measures

Measure	Paricalcitol IV n=105 Participants Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Paricalcitol IV: Week 12 Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Paricalcitol IV: Week 24 Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL Baseline to Week 12; n=70	14 participants	—	—
Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL Week 12 to Week 24; n=50	14 participants	—	—

SECONDARY outcome

Timeframe: Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)

Population: All participants; n=number of participants with valid PTH values at given time point.

Number of participants achieving PTH level reductions to < 300 pg/mL or 30% below Baseline in 12 weeks (Baseline to Week 12 or Week 12 to Week 24) or in 24 weeks (Baseline to Week 24).

Outcome measures

Measure	Paricalcitol IV n=105 Participants Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Paricalcitol IV: Week 12 Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Paricalcitol IV: Week 24 Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks Baseline to Week 12 (12 weeks); n=70	14 participants	—	—
Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks Week 12 to Week 24 (12 weeks); n=50	13 participants	—	—
Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks Baseline to Week 24 (24 weeks); n=50	16 participants	—	—

SECONDARY outcome

Timeframe: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)

Population: Participants with valid assessments at given time point.

The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a visual analogue scale (VAS). For each parameter other than the VAS, participants are asked to indicate which of 5 statements (from 'no problem' to 'extreme problem') best describes their health state.

Outcome measures

Measure	Paricalcitol IV n=104 Participants Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Paricalcitol IV: Week 12 n=70 Participants Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Paricalcitol IV: Week 24 n=50 Participants Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Pain/Discomfort: Severe	2 participants	1 participants	1 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Pain/Discomfort: Extreme	2 participants	0 participants	0 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Pain/Discomfort: Unknown	7 participants	10 participants	0 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Anxiety/Depression: None	66 participants	46 participants	39 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Anxiety/Depression: Slight	24 participants	11 participants	9 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Anxiety/Depression: Moderate	4 participants	2 participants	2 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Anxiety/Depression: Severe	3 participants	0 participants	0 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Anxiety/Depression: Extreme	0 participants	0 participants	0 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Anxiety/Depression: Unknown	7 participants	11 participants	0 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Mobility: No Problems	64 participants	36 participants	27 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Mobility: Slight Problems	13 participants	15 participants	13 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Mobility: Moderate Problems	13 participants	6 participants	8 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Mobility: Severe Problems	5 participants	3 participants	2 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Mobility: Unable to Walk About	1 participants	0 participants	0 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Mobility: Unknown	8 participants	10 participants	0 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Self-Care: No Problems	80 participants	50 participants	40 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Self-Care: Slight Problems	8 participants	3 participants	7 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Self-Care: Moderate Problems	5 participants	3 participants	3 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Self-Care: Severe Problems	0 participants	3 participants	0 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Self-Care: Unable to Wash or Dress Self	3 participants	1 participants	0 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Self-Care: Unknown	8 participants	10 participants	0 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Usual Activities: No Problems	53 participants	37 participants	28 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Usual Activities: Slight Problems	26 participants	13 participants	15 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Usual Activities: Moderate Problems	9 participants	6 participants	5 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Usual Activities: Severe Problems	5 participants	2 participants	1 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Usual Activities: Unable to Do Usual Activities	3 participants	2 participants	1 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Usual Activities: Unknown	8 participants	10 participants	0 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Pain/Discomfort: None	39 participants	30 participants	21 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Pain/Discomfort: Slight	41 participants	20 participants	18 participants
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Pain/Discomfort: Moderate	13 participants	9 participants	10 participants

SECONDARY outcome

Timeframe: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)

Population: Participants with valid assessments at given time point.

The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a VAS. For the VAS portion, health status is assessed by participants on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'worst imaginable health state' (0) and 'best imaginable health state' (100).

Outcome measures

Measure	Paricalcitol IV n=94 Participants Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Paricalcitol IV: Week 12 n=59 Participants Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Paricalcitol IV: Week 24 n=48 Participants Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24	77.98 units on a scale Standard Deviation 16.21	84.31 units on a scale Standard Deviation 14.52	80.33 units on a scale Standard Deviation 18.28

SECONDARY outcome

Timeframe: Baseline Week 1 (Study Visit 1), Week 24 (Final Study Visit)

Population: Participants with a complete, valid assessment at given time point.

BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression. The range of scores is 0 to 63, with a higher value representing a worse outcome.

Outcome measures

Measure	Paricalcitol IV n=88 Participants Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Paricalcitol IV: Week 12 n=45 Participants Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Paricalcitol IV: Week 24 Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit	10.39 units on a scale Standard Deviation 7.04	7.96 units on a scale Standard Deviation 5.75	—

Adverse Events

Paricalcitol IV

Serious events: 9 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Paricalcitol IV n=105 participants at risk Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.95% 1/105 • From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid adenoma	0.95% 1/105 • From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.
Cardiac disorders Cardio-respiratory arrest	0.95% 1/105 • From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.
Cardiac disorders Heart failure	0.95% 1/105 • From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.
Cardiac disorders Myocardial infarction	0.95% 1/105 • From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.
Infections and infestations Sepsis	1.9% 2/105 • From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.
Musculoskeletal and connective tissue disorders Spinal cord compression	0.95% 1/105 • From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.
Social circumstances Drowning	0.95% 1/105 • From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.

Other adverse events

Measure	Paricalcitol IV n=105 participants at risk Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
Gastrointestinal disorders Gastritis	5.7% 6/105 • From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.
Nervous system disorders Insomnia	3.8% 4/105 • From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.
Nervous system disorders Neuropathic pain	1.9% 2/105 • From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.
Infections and infestations Catheter related infection	1.9% 2/105 • From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.
Infections and infestations Pharyngitis	0.95% 1/105 • From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.
Infections and infestations Upper respiratory infection	0.95% 1/105 • From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.
Musculoskeletal and connective tissue disorders Pain in extremities	0.95% 1/105 • From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.95% 1/105 • From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.
General disorders Pain	0.95% 1/105 • From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.
Cardiac disorders Chest pain	0.95% 1/105 • From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.
Vascular disorders Hypotension	0.95% 1/105 • From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.

Additional Information

Global Medical Services

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER