Trial Outcomes & Findings for A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin (NCT NCT00995566)

NCT ID: NCT00995566

Last Updated: 2012-02-07

Results Overview

Elevated liver function: greater than 3 times the upper limit of normal (\>3 x ULN) alanine aminotransferase (ALT) and aspartase aminotransferase (AST) levels. Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.

• Recruitment status: TERMINATED
• Target enrollment: 54 participants
• Primary outcome timeframe: Monthly up to 1 year
• Results posted on: 2012-02-07

Participant Flow

The Sitaxentan Sodium program was discontinued December 10, 2010.

Participant milestones

Measure	Thelin Registry Patients The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
Overall Study STARTED	54
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	54

Reasons for withdrawal

Measure	Thelin Registry Patients The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
Overall Study Adverse Event	2
Overall Study Early study termination	52

Baseline Characteristics

A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin

Baseline characteristics by cohort

Measure	Thelin Registry Patients n=54 Participants The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
Age Continuous	60.5 years STANDARD_DEVIATION 18.1 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Monthly up to 1 year

Population: Full Analysis Set (FAS): participants enrolled in Patient Registry of Sitaxentan in Europe (PROSE). Number of participants analyzed (N): participants with evaluable data.

Elevated liver function: greater than 3 times the upper limit of normal (>3 x ULN) alanine aminotransferase (ALT) and aspartase aminotransferase (AST) levels. Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.

Outcome measures

Measure	Thelin Registry Patients n=45 Participants The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
Percentage of Participants With Elevated Liver Function Post-baseline ALT >3 xULN	2.2 percentage of participants
Percentage of Participants With Elevated Liver Function Post-baseline AST >3 xULN	2.2 percentage of participants

PRIMARY outcome

Timeframe: Monthly up to 1 year

Population: Data not summarized due to the small number of participants in database.

Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Monthly up to 1 year

Population: Data not summarized due to the small number of participants in database.

Total and conjugated bilirubin levels measured from blood, but indirect bilirubin calculated. Indirect bilirubin=Total bilirubin - Conjugated bilirubin. Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 Year

Population: FAS

Time between the first and last dose of Thelin. For participants who continued Thelin from TOPS (another study), the initial TOPS' Thelin start date was used.

Outcome measures

Measure	Thelin Registry Patients n=54 Participants The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
Duration of Exposure to Thelin	21.5 months Standard Deviation 15.3

PRIMARY outcome

Timeframe: Baseline up to year 1

Population: FAS

Counts of participants who had AEs or treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Serious adverse events (SAEs) were reported from the time of informed consent. Relatedness to Thelin was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

Outcome measures

Measure	Thelin Registry Patients n=54 Participants The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
Adverse Events (AEs) by Seriousness and Relationship to Treatment Any TEAE	11 participants
Adverse Events (AEs) by Seriousness and Relationship to Treatment TEAE related to Thelin	1 participants
Adverse Events (AEs) by Seriousness and Relationship to Treatment SAE	6 participants
Adverse Events (AEs) by Seriousness and Relationship to Treatment SAE related to Thelin	1 participants

PRIMARY outcome

Timeframe: Monthly up to 1 year

Population: Data not summarized due to the small number of participants in database.

Clinical status determined by status of pulmonary arterial hypertension (PAH) since last visit, reported as PAH remained stable, improved or deteriorated.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, monthly up to 1 year

Population: Data not summarized due to the small number of participants in database.

Number of participants with concomitant medication usage reported by drug categories.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline up to year 1

Population: FAS

Counts of participants who had bleeding events or treatment-emergent bleeding events, defined as newly occurring or worsening after first dose. Serious bleeding events reported from time of informed consent. Relatedness to Thelin assessed by investigator (Yes/No). ERA usage: was participant taking Vitamin K antagonist? (Yes/No). INR: participant's prothrombin time (PT) ratio. Participants with multiple occurrences of an AE within a category were counted once within the category.

Outcome measures

Measure	Thelin Registry Patients n=54 Participants The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
Bleeding AEs by Seriousness, Relationship to Treatment, Endothelin-A Receptor Antagonist (ERA) Usage, and International Normalized Ratio (INR) Results Any bleeding event	1 participants
Bleeding AEs by Seriousness, Relationship to Treatment, Endothelin-A Receptor Antagonist (ERA) Usage, and International Normalized Ratio (INR) Results Bleeding event related to Thelin	0 participants
Bleeding AEs by Seriousness, Relationship to Treatment, Endothelin-A Receptor Antagonist (ERA) Usage, and International Normalized Ratio (INR) Results Serious bleeding event	0 participants
Bleeding AEs by Seriousness, Relationship to Treatment, Endothelin-A Receptor Antagonist (ERA) Usage, and International Normalized Ratio (INR) Results Serious bleeding event related to Thelin	0 participants
Bleeding AEs by Seriousness, Relationship to Treatment, Endothelin-A Receptor Antagonist (ERA) Usage, and International Normalized Ratio (INR) Results Bleeding event with ERA usage	0 participants
Bleeding AEs by Seriousness, Relationship to Treatment, Endothelin-A Receptor Antagonist (ERA) Usage, and International Normalized Ratio (INR) Results Bleeding event with INR results	0 participants

PRIMARY outcome

Timeframe: Baseline up to year 1

Population: FAS

The criteria used to determine whether participants had both pulmonary edema and veno-occlusive disease was at the discretion of the Investigator.

Outcome measures

Measure	Thelin Registry Patients n=54 Participants The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
Percentage of Participants Who Experienced Pulmonary Edema With the Presence of Veno-occlusive Disease	0 percentage of participants

Adverse Events

Thelin Registry Patients

Serious events: 6 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Thelin Registry Patients n=54 participants at risk The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
Cardiac disorders Cardiac failure	5.6% 3/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Endocrine disorders Hyperparathyroidism primary	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
General disorders Oedema	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatitis toxic	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Injection site infection	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Paraesthesia	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Agitation	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Measure	Thelin Registry Patients n=54 participants at risk The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
Cardiac disorders Atrial tachycardia	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Anal haemorrhage	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthritis	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypotension	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER