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Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00666198
Recruitment Status : Completed
First Posted : April 24, 2008
Results First Posted : April 24, 2017
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Pulmonary Hypertension
Intervention Drug: SILDENAFIL
Enrollment 3337
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Revatio (Sildenafil Citrate)
Hide Arm/Group Description Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
Period Title: Overall Study
Started 3337
Completed 3304
Not Completed 33
Reason Not Completed
Protocol Violation             10
No Visit After First Day of Treatment             13
Safety Not Assessable             6
No Drug Administration             4
Arm/Group Title Revatio (Sildenafil Citrate)
Hide Arm/Group Description Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
Overall Number of Baseline Participants 3304
Hide Baseline Analysis Population Description
A total of 3304 participants received sildenafil citrate at least once in this study. Of the 3304 participants, 33 participants were excluded from the baseline analysis due to following reasons: protocol violation, no visit after first day of treatment, safety not assessable and no drug administration.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3304 participants
˂65 years 2406
≥65 years 898
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3304 participants
˂15 years 1050
≥15 years 2254
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3304 participants
Female 2057
Male 1247
Disease Type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3304 participants
Idiopathic/Familial PAH (IPAH/FPAH) 745
Collagen Vascular Disease* 666
Congenital Systemic to Pulmonary Shunts* 985
PVOD/PCH** 44
Persistent PH of the Newborn (PPHN) 59
Other PAH (Portal Hypertention/HIV Infection etc.) 139
Other Than PAH 665
Unknown 1
[1]
Measure Description: Categorization of PAH in the study. * indicates "Associated Pulmonary Arterial Hypertension (APAH)". ** refers to "Pulmonary Veno Occlusive Disease/Pulmonary Capillary Hemangiomatosis".
WHO Functional Classification of PAH   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3304 participants
Class I 344
Class II 1012
Class III 1279
Class IV 545
Not Classified 124
[1]
Measure Description: This system grades PAH severity according to the functional status of the patient. The grades range from Functional Class (FC) I, where the patient's disease does not affect their day-to-day activities, to FC IV, where patients are severely functionally impaired, even at rest. This functional classification system links symptoms with activity limitations, and allows clinicians to quickly predict disease progression and prognosis, as well as the need for specific treatment regimens, irrespective of the underlying etiology of PAH.
1.Primary Outcome
Title Number of Participants With Treatment-Related Adverse Events
Hide Description A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sildenafil citrate was assessed by the physician/investigator.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.
Arm/Group Title Revatio (Sildenafil Citrate)
Hide Arm/Group Description:
Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 3304
Measure Type: Number
Unit of Measure: Participants
Treatment-Related Adverse Event 448
Treatment-Related Serious Adverse Event 101
2.Primary Outcome
Title Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
Hide Description A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sildenafil citrate was assessed by the physician/investigator.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.
Arm/Group Title Revatio (Sildenafil Citrate)
Hide Arm/Group Description:
Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 3304
Measure Type: Number
Unit of Measure: Participants
196
3.Primary Outcome
Title Number of Paritcipants With Treatment-Related Adverse Events by Age
Hide Description A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by age to assess whether it was risk factor for the treatment related adverse events.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.
Arm/Group Title Revatio (Sildenafil Citrate)
Hide Arm/Group Description:
Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 3304
Measure Type: Number
Unit of Measure: Paritcipants
˂15 years (n=1050) 57
≥15 years (n=2254) 391
4.Primary Outcome
Title Number of Paritcipants With Treatment-Related Adverse Events by Gender
Hide Description A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by gender to assess whether it was risk factor for the treatment related adverse events.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.
Arm/Group Title Revatio (Sildenafil Citrate)
Hide Arm/Group Description:
Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 3304
Measure Type: Number
Unit of Measure: Paritcipants
Female (n=2057) 323
Male (n=1247) 125
5.Primary Outcome
Title Number of Participants With Treatment-Related Adverse Events by Disease Type
Hide Description

A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by disease type to assess whether it was risk factor for the treatment related adverse events.

* indicates "Associated Pulmonary Arterial Hypertension (APAH)". ** refers to "Pulmonary Veno Occlusive Disease/Pulmonary Capillary Hemangiomatosis".

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.
Arm/Group Title Revatio (Sildenafil Citrate)
Hide Arm/Group Description:
Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 3304
Measure Type: Number
Unit of Measure: Participants
Idiopathic/Familial PAH(IPAH/FPAH) (n=745) 116
Collagen Vascular Disease* (n=666) 136
Congenital Systemic to Pulmonary Shunts* (n=985) 66
PVOD/PCH** (n=44) 4
Persistent PH of the Newborn (PPHN) (n=59) 3
Other PAH (n=139) 25
Other Than PAH (n=665) 98
Unkown (n=1) 0
6.Primary Outcome
Title Number of Participants With Treatmnt-Related Adverse Events by WHO Functional Classification of Severity
Hide Description A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by severity (WHO functional classification for PAH range;This system grades PAH severity according to the functional status of the patient. The grades range from Functional Class (FC) I, where the patient's disease does not affect their day-to-day activities, to FC IV, where patients are severely functionally impaired, even at rest. This functional classification system links symptoms with activity limitations, and allows clinicians to quickly predict disease progression and prognosis, as well as the need for specific treatment regimens, irrespective of the underlying etiology of PAH) to assess whether it was risk factor for the treatment related adverse events.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.
Arm/Group Title Revatio (Sildenafil Citrate)
Hide Arm/Group Description:
Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 3304
Measure Type: Number
Unit of Measure: Participants
Class I (n=344) 34
Class II (n=1012) 127
Class III (n=1279) 204
Class IV (n=545) 63
Not Classified (n=124) 20
7.Primary Outcome
Title Clinical Efficacy Rate by Age
Hide Description Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as “effective,” “ineffective” or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by age were counted to assess whether it contributes to the clinical effectiveness.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.
Arm/Group Title Revatio (Sildenafil Citrate)
Hide Arm/Group Description:
Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 3301
Measure Type: Number
Unit of Measure: Percentage of Participants
˂15 years (n=1049) 72.0
≥15 years (n=2252) 62.0
8.Primary Outcome
Title Clinical Efficacy Rate by Gender
Hide Description Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as “effective,” “ineffective” or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by gender were counted to assess whether it contributes to the clinical effectiveness.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.
Arm/Group Title Revatio (Sildenafil Citrate)
Hide Arm/Group Description:
Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 3301
Measure Type: Number
Unit of Measure: Percentage of Participants
Female (n=2054) 65.9
Male (n=1247) 64.0
9.Primary Outcome
Title Clinical Efficacy Rate by Disease Type
Hide Description

Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as “effective,” “ineffective” or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by disease type were counted to assess whether it contributes to the clinical effectiveness.

* indicates "Associated Pulmonary Arterial Hypertension (APAH)". ** refers to "Pulmonary Veno Occlusive Disease/Pulmonary Capillary Hemangiomatosis".

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.
Arm/Group Title Revatio (Sildenafil Citrate)
Hide Arm/Group Description:
Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 3301
Measure Type: Number
Unit of Measure: Percentage of Participants
Idiopathic/Familial PAH(IPAH/FPAH) (n=743) 67.6
Collagen Vascular Disease* (n=666) 61.6
Congenital Systemic to Pulmonary Shunts* (n=984) 72.9
PVOD/PCH** (n=44) 40.9
Persistent PH of the Newborn (PPHN) (n=59) 55.9
Other PAH (n=139) 67.6
Other Than PAH (n=665) 56.5
Unknown (n=1) 100.0
10.Primary Outcome
Title Clinical Efficacy Rate by WHO Functional Classificaton of Severity
Hide Description Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as “effective,” “ineffective” or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by severity (WHO functional classification of PAH;The grades range from Functional Class (FC) I, where the patient's disease does not affect their day-to-day activities, to FC IV, where patients are severely functionally impaired, even at rest. This functional classification system links) were counted to assess whether it contributes to the clinical effectiveness.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.
Arm/Group Title Revatio (Sildenafil Citrate)
Hide Arm/Group Description:
Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 3301
Measure Type: Number
Unit of Measure: Percentage of Participants
Class I (n=344) 76.2
Class II (n=1010) 70.5
Class III (n=1279) 64.2
Class IV (n=544) 52.4
Not Classified (n=124) 57.3
Time Frame [Not Specified]
Adverse Event Reporting Description The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Revatio (Sildenafil Citrate)
Hide Arm/Group Description Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
All-Cause Mortality
Revatio (Sildenafil Citrate)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Revatio (Sildenafil Citrate)
Affected / at Risk (%)
Total   982/3304 (29.72%) 
Blood and lymphatic system disorders   
Abnormal clotting factor * 1  1/3304 (0.03%) 
Agranulocytosis * 1  1/3304 (0.03%) 
Anaemia * 1  19/3304 (0.58%) 
Anaemia neonatal * 1  1/3304 (0.03%) 
Anaemia vitamin B12 deficiency * 1  1/3304 (0.03%) 
Coagulopathy * 1  1/3304 (0.03%) 
Disseminated intravascular coagulation * 1  10/3304 (0.30%) 
Haemorrhagic anaemia * 1  2/3304 (0.06%) 
Histiocytosis haematophagic * 1  2/3304 (0.06%) 
Immune thrombocytopenic purpura * 1  1/3304 (0.03%) 
Nephrogenic anaemia * 1  3/3304 (0.09%) 
Pancytopenia * 1  3/3304 (0.09%) 
Splenic infarction * 1  1/3304 (0.03%) 
Thrombocytopenia * 1  7/3304 (0.21%) 
Thrombocytosis * 1  1/3304 (0.03%) 
Cardiac disorders   
Acute myocardial infarction * 1  1/3304 (0.03%) 
Angina pectoris * 1  1/3304 (0.03%) 
Angina unstable * 1  1/3304 (0.03%) 
Aortic valve stenosis * 1  1/3304 (0.03%) 
Arrhythmia * 1  5/3304 (0.15%) 
Atrial fibrillation * 1  8/3304 (0.24%) 
Atrial flutter * 1  5/3304 (0.15%) 
Atrial tachycardia * 1  4/3304 (0.12%) 
Atrioventricular block * 1  1/3304 (0.03%) 
Atrioventricular block complete * 1  2/3304 (0.06%) 
Bradyarrhythmia * 1  1/3304 (0.03%) 
Bradycardia * 1  3/3304 (0.09%) 
Cardiac arrest * 1  14/3304 (0.42%) 
Cardiac failure * 1  156/3304 (4.72%) 
Cardiac failure acute * 1  8/3304 (0.24%) 
Cardiac failure chronic * 1  16/3304 (0.48%) 
Cardiac failure congestive * 1  18/3304 (0.54%) 
Cardiac tamponade * 1  1/3304 (0.03%) 
Cardiac valve disease * 1  1/3304 (0.03%) 
Cardiogenic shock * 1  3/3304 (0.09%) 
Cardio-respiratory arrest * 1  12/3304 (0.36%) 
Cardiovascular insufficiency * 1  1/3304 (0.03%) 
Cor pulmonale * 1  6/3304 (0.18%) 
Left ventricular dysfunction * 1  1/3304 (0.03%) 
Low cardiac output syndrome * 1  4/3304 (0.12%) 
Myocardial infarction * 1  1/3304 (0.03%) 
Myocardial ischaemia * 1  1/3304 (0.03%) 
Myocarditis * 1  1/3304 (0.03%) 
Palpitations * 1  5/3304 (0.15%) 
Pericardial effusion * 1  2/3304 (0.06%) 
Pericarditis constrictive * 1  1/3304 (0.03%) 
Prinzmetal angina * 1  1/3304 (0.03%) 
Right ventricular failure * 1  44/3304 (1.33%) 
Sinus bradycardia * 1  1/3304 (0.03%) 
Supraventricular extrasystoles * 1  1/3304 (0.03%) 
Supraventricular tachycardia * 1  3/3304 (0.09%) 
Tachyarrhythmia * 1  1/3304 (0.03%) 
Tachycardia * 1  4/3304 (0.12%) 
Tricuspid valve incompetence * 1  1/3304 (0.03%) 
Ventricular extrasystoles * 1  2/3304 (0.06%) 
Ventricular fibrillation * 1  5/3304 (0.15%) 
Ventricular tachycardia * 1  6/3304 (0.18%) 
Congenital, familial and genetic disorders   
Anomalous pulmonary venous connection * 1  2/3304 (0.06%) 
Atrial septal defect * 1  2/3304 (0.06%) 
Congenital diaphragmatic hernia * 1  1/3304 (0.03%) 
Congenital mitral valve stenosis * 1  1/3304 (0.03%) 
Familial mediterranean fever * 1  1/3304 (0.03%) 
Hydrocele * 1  1/3304 (0.03%) 
Interruption of aortic arch * 1  1/3304 (0.03%) 
Mitochondrial myopathy * 1  1/3304 (0.03%) 
Persistent foetal circulation * 1  4/3304 (0.12%) 
Pulmonary arteriovenous fistula * 1  2/3304 (0.06%) 
Pulmonary artery atresia * 1  2/3304 (0.06%) 
Pulmonary hypoplasia * 1  1/3304 (0.03%) 
Pyloric stenosis * 1  1/3304 (0.03%) 
Ear and labyrinth disorders   
Sudden hearing loss * 1  1/3304 (0.03%) 
Endocrine disorders   
Adrenocorticotropic hormone deficiency * 1  1/3304 (0.03%) 
Hyperthyroidism * 1  1/3304 (0.03%) 
Hypothyroidism * 1  2/3304 (0.06%) 
Eye disorders   
Visual impairment * 1  1/3304 (0.03%) 
Vitreous haemorrhage * 1  1/3304 (0.03%) 
Gastrointestinal disorders   
Abdominal distension * 1  2/3304 (0.06%) 
Abdominal pain * 1  4/3304 (0.12%) 
Ascites * 1  6/3304 (0.18%) 
Colitis ischaemic * 1  1/3304 (0.03%) 
Constipation * 1  1/3304 (0.03%) 
Diarrhoea * 1  7/3304 (0.21%) 
Diverticulum intestinal haemorrhagic * 1  2/3304 (0.06%) 
Duodenal ulcer haemorrhage * 1  1/3304 (0.03%) 
Dysphagia * 1  1/3304 (0.03%) 
Enterocolitis * 1  3/3304 (0.09%) 
Faeces discoloured * 1  1/3304 (0.03%) 
Gastric haemorrhage * 1  1/3304 (0.03%) 
Gastric mucosal lesion * 1  1/3304 (0.03%) 
Gastric ulcer haemorrhage * 1  1/3304 (0.03%) 
Gastritis * 1  1/3304 (0.03%) 
Gastritis erosive * 1  1/3304 (0.03%) 
Gastritis haemorrhagic * 1  1/3304 (0.03%) 
Gastroduodenal ulcer * 1  1/3304 (0.03%) 
Gastrointestinal haemorrhage * 1  7/3304 (0.21%) 
Gastrointestinal hypomotility * 1  2/3304 (0.06%) 
Gastrointestinal motility disorder * 1  1/3304 (0.03%) 
Gastrointestinal necrosis * 1  2/3304 (0.06%) 
Gastrooesophageal reflux disease * 1  1/3304 (0.03%) 
Haematemesis * 1  1/3304 (0.03%) 
Haemorrhoids * 1  1/3304 (0.03%) 
Ileus * 1  5/3304 (0.15%) 
Ileus paralytic * 1  1/3304 (0.03%) 
Incarcerated inguinal hernia * 1  1/3304 (0.03%) 
Incarcerated umbilical hernia * 1  1/3304 (0.03%) 
Inguinal hernia * 1  1/3304 (0.03%) 
Intestinal obstruction * 1  3/3304 (0.09%) 
Melaena * 1  1/3304 (0.03%) 
Nausea * 1  2/3304 (0.06%) 
Oesophageal fistula * 1  1/3304 (0.03%) 
Oesophageal varices haemorrhage * 1  2/3304 (0.06%) 
Pancreatitis * 1  1/3304 (0.03%) 
Pancreatitis acute * 1  1/3304 (0.03%) 
Peptic ulcer * 1  1/3304 (0.03%) 
Portal venous gas * 1  1/3304 (0.03%) 
Protein-losing gastroenteropathy * 1  5/3304 (0.15%) 
Rectal polyp * 1  1/3304 (0.03%) 
Subileus * 1  1/3304 (0.03%) 
Upper gastrointestinal haemorrhage * 1  6/3304 (0.18%) 
Volvulus * 1  1/3304 (0.03%) 
Vomiting * 1  6/3304 (0.18%) 
General disorders   
Catheter site erythema * 1  1/3304 (0.03%) 
Catheter site induration * 1  1/3304 (0.03%) 
Catheter site swelling * 1  1/3304 (0.03%) 
Chest pain * 1  1/3304 (0.03%) 
Condition aggravated * 1  3/3304 (0.09%) 
Death * 1  24/3304 (0.73%) 
Device breakage * 1  2/3304 (0.06%) 
Device connection issue * 1  1/3304 (0.03%) 
Device damage * 1  3/3304 (0.09%) 
Device pacing issue * 1  1/3304 (0.03%) 
Disease progression * 1  13/3304 (0.39%) 
Food interaction * 1  1/3304 (0.03%) 
General physical health deterioration * 1  1/3304 (0.03%) 
Generalised oedema * 1  3/3304 (0.09%) 
Inflammation * 1  1/3304 (0.03%) 
Malaise * 1  2/3304 (0.06%) 
Multi-organ failure * 1  17/3304 (0.51%) 
Oedema * 1  3/3304 (0.09%) 
Oedema peripheral * 1  3/3304 (0.09%) 
Pyrexia * 1  7/3304 (0.21%) 
Sudden cardiac death * 1  1/3304 (0.03%) 
Sudden death * 1  4/3304 (0.12%) 
Sudden infant death syndrome * 1  1/3304 (0.03%) 
Thirst * 1  2/3304 (0.06%) 
Hepatobiliary disorders   
Biliary cirrhosis * 1  1/3304 (0.03%) 
Cholecystitis * 1  3/3304 (0.09%) 
Cholecystitis acute * 1  1/3304 (0.03%) 
Cholelithiasis * 1  1/3304 (0.03%) 
Hepatic cirrhosis * 1  7/3304 (0.21%) 
Hepatic congestion * 1  1/3304 (0.03%) 
Hepatic failure * 1  9/3304 (0.27%) 
Hepatic function abnormal * 1  25/3304 (0.76%) 
Hepatitis * 1  1/3304 (0.03%) 
Hepatocellular injury * 1  1/3304 (0.03%) 
Hepatomegaly * 1  1/3304 (0.03%) 
Hepatorenal syndrome * 1  1/3304 (0.03%) 
Liver disorder * 1  4/3304 (0.12%) 
Portal hypertension * 1  2/3304 (0.06%) 
Immune system disorders   
Allergic granulomatous angiitis * 1  1/3304 (0.03%) 
Anti-neutrophil cytoplasmic antibody positive vasculitis * 1  1/3304 (0.03%) 
Infections and infestations   
Appendicitis * 1  3/3304 (0.09%) 
Bacteraemia * 1  3/3304 (0.09%) 
Conjunctivitis * 1  1/3304 (0.03%) 
Cellulitis * 1  3/3304 (0.09%) 
Campylobacter gastroenteritis * 1  1/3304 (0.03%) 
Bronchopulmonary aspergillosis * 1  3/3304 (0.09%) 
Bronchopneumonia * 1  2/3304 (0.06%) 
Bronchitis * 1  19/3304 (0.58%) 
Bronchiolitis * 1  1/3304 (0.03%) 
Brain abscess * 1  2/3304 (0.06%) 
Cytomegalovirus infection * 1  4/3304 (0.12%) 
Disseminated tuberculosis * 1  1/3304 (0.03%) 
Epiglottitis * 1  1/3304 (0.03%) 
Gangrene * 1  1/3304 (0.03%) 
Gastroenteritis * 1  2/3304 (0.06%) 
Gastroenteritis adenovirus * 1  1/3304 (0.03%) 
Gastroenteritis rotavirus * 1  2/3304 (0.06%) 
Hepatitis A * 1  1/3304 (0.03%) 
Infection * 1  6/3304 (0.18%) 
Influenza * 1  7/3304 (0.21%) 
Laryngitis * 1  1/3304 (0.03%) 
Lobar pneumonia * 1  1/3304 (0.03%) 
Meningitis * 1  4/3304 (0.12%) 
Meningitis aseptic * 1  1/3304 (0.03%) 
Nasopharyngitis * 1  4/3304 (0.12%) 
Oesophageal candidiasis * 1  1/3304 (0.03%) 
Otitis media acute * 1  1/3304 (0.03%) 
Peritonitis * 1  3/3304 (0.09%) 
Pharyngitis * 1  1/3304 (0.03%) 
Pneumonia * 1  86/3304 (2.60%) 
Pneumonia cytomegaloviral * 1  1/3304 (0.03%) 
Pneumonia influenzal * 1  1/3304 (0.03%) 
Pneumonia mycoplasmal * 1  2/3304 (0.06%) 
Pneumonia staphylococcal * 1  2/3304 (0.06%) 
Pseudomembranous colitis * 1  2/3304 (0.06%) 
Pulmonary mycosis * 1  1/3304 (0.03%) 
Pyelonephritis * 1  3/3304 (0.09%) 
Respiratory syncytial virus bronchiolitis * 1  3/3304 (0.09%) 
Sepsis * 1  20/3304 (0.61%) 
Septic embolus * 1  1/3304 (0.03%) 
Septic shock * 1  7/3304 (0.21%) 
Sinusitis * 1  1/3304 (0.03%) 
Urinary tract infection * 1  2/3304 (0.06%) 
Viral infection * 1  1/3304 (0.03%) 
Staphylococcal bacteraemia * 1  1/3304 (0.03%) 
Infusion site infection * 1  1/3304 (0.03%) 
Staphylococcal sepsis * 1  3/3304 (0.09%) 
Catheter site infection * 1  6/3304 (0.18%) 
Phlebitis infective * 1  1/3304 (0.03%) 
Wound abscess * 1  1/3304 (0.03%) 
Staphylococcal infection * 1  1/3304 (0.03%) 
Enteritis infectious * 1  2/3304 (0.06%) 
Klebsiella bacteraemia * 1  1/3304 (0.03%) 
Adenovirus infection * 1  1/3304 (0.03%) 
Bacterial infection * 1  1/3304 (0.03%) 
Pneumonia bacterial * 1  10/3304 (0.30%) 
Serratia infection * 1  1/3304 (0.03%) 
Respiratory syncytial virus infection * 1  1/3304 (0.03%) 
Atypical mycobacterial infection * 1  1/3304 (0.03%) 
Peritonitis bacterial * 1  1/3304 (0.03%) 
Respiratory tract infection * 1  3/3304 (0.09%) 
Puncture site infection * 1  3/3304 (0.09%) 
Device related infection * 1  26/3304 (0.79%) 
Device related sepsis * 1  1/3304 (0.03%) 
Pneumocystis jirovecii pneumonia * 1  3/3304 (0.09%) 
Candida infection * 1  1/3304 (0.03%) 
Varicella zoster pneumonia * 1  1/3304 (0.03%) 
Cholangitis infective * 1  1/3304 (0.03%) 
Injury, poisoning and procedural complications   
Arterial injury * 1  1/3304 (0.03%) 
Compression fracture * 1  4/3304 (0.12%) 
Fall * 1  3/3304 (0.09%) 
Femur fracture * 1  1/3304 (0.03%) 
Lumbar vertebral fracture * 1  2/3304 (0.06%) 
Post procedural complication * 1  1/3304 (0.03%) 
Post procedural haemorrhage * 1  1/3304 (0.03%) 
Postpericardiotomy syndrome * 1  1/3304 (0.03%) 
Procedural complication * 1  1/3304 (0.03%) 
Radiation pneumonitis * 1  1/3304 (0.03%) 
Rib fracture * 1  1/3304 (0.03%) 
Shunt malfunction * 1  1/3304 (0.03%) 
Spinal compression fracture * 1  1/3304 (0.03%) 
Stab wound * 1  1/3304 (0.03%) 
Subdural haematoma * 1  7/3304 (0.21%) 
Toxicity to various agents * 1  1/3304 (0.03%) 
Tracheal haemorrhage * 1  1/3304 (0.03%) 
Upper limb fracture * 1  1/3304 (0.03%) 
Investigations   
Alanine aminotransferase increased * 1  2/3304 (0.06%) 
Aspartate aminotransferase increased * 1  2/3304 (0.06%) 
Blood creatinine increased * 1  1/3304 (0.03%) 
Blood glucose abnormal * 1  1/3304 (0.03%) 
Blood pressure decreased * 1  9/3304 (0.27%) 
Blood pressure increased * 1  1/3304 (0.03%) 
Brain natriuretic peptide increased * 1  7/3304 (0.21%) 
Carbon dioxide increased * 1  1/3304 (0.03%) 
Cardiac output decreased * 1  1/3304 (0.03%) 
Chest X-ray abnormal * 1  1/3304 (0.03%) 
Computerised tomogram thorax abnormal * 1  1/3304 (0.03%) 
Electrocardiogram QT prolonged * 1  1/3304 (0.03%) 
Haemoglobin decreased * 1  2/3304 (0.06%) 
International normalised ratio increased * 1  3/3304 (0.09%) 
Liver function test abnormal * 1  1/3304 (0.03%) 
Platelet count decreased * 1  12/3304 (0.36%) 
Pulmonary arterial pressure increased * 1  2/3304 (0.06%) 
Serum ferritin increased * 1  1/3304 (0.03%) 
Urine output decreased * 1  1/3304 (0.03%) 
Weight increased * 1  1/3304 (0.03%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  3/3304 (0.09%) 
Dehydration * 1  11/3304 (0.33%) 
Diabetes mellitus * 1  3/3304 (0.09%) 
Hyperammonaemia * 1  1/3304 (0.03%) 
Hypercalcaemia * 1  1/3304 (0.03%) 
Hyperkalaemia * 1  4/3304 (0.12%) 
Hypoalbuminaemia * 1  3/3304 (0.09%) 
Hypoglycaemia * 1  3/3304 (0.09%) 
Hypokalaemia * 1  7/3304 (0.21%) 
Hyponatraemia * 1  2/3304 (0.06%) 
Hypoproteinaemia * 1  1/3304 (0.03%) 
Malnutrition * 1  2/3304 (0.06%) 
Metabolic acidosis * 1  2/3304 (0.06%) 
Metabolic alkalosis * 1  1/3304 (0.03%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/3304 (0.03%) 
Bursitis * 1  1/3304 (0.03%) 
Intervertebral disc protrusion * 1  2/3304 (0.06%) 
Musculoskeletal stiffness * 1  1/3304 (0.03%) 
Osteoarthritis * 1  1/3304 (0.03%) 
Osteonecrosis * 1  2/3304 (0.06%) 
Rheumatoid arthritis * 1  2/3304 (0.06%) 
Spinal pain * 1  1/3304 (0.03%) 
Systemic lupus erythematosus * 1  1/3304 (0.03%) 
Systemic sclerosis * 1  1/3304 (0.03%) 
Arthritis * 1  1/3304 (0.03%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute leukaemia * 1  2/3304 (0.06%) 
Bladder cancer * 1  2/3304 (0.06%) 
Borderline ovarian tumour * 1  1/3304 (0.03%) 
Breast cancer * 1  2/3304 (0.06%) 
Cervix carcinoma * 1  1/3304 (0.03%) 
Chronic myeloid leukaemia * 1  1/3304 (0.03%) 
Colon cancer * 1  3/3304 (0.09%) 
Gallbladder cancer * 1  1/3304 (0.03%) 
Gastric cancer * 1  7/3304 (0.21%) 
Gingival cancer * 1  1/3304 (0.03%) 
Hepatocellular carcinoma * 1  2/3304 (0.06%) 
Lung adenocarcinoma * 1  2/3304 (0.06%) 
Lung neoplasm * 1  1/3304 (0.03%) 
Lung neoplasm malignant * 1  8/3304 (0.24%) 
Malignant ascites * 1  1/3304 (0.03%) 
Metastases to central nervous system * 1  1/3304 (0.03%) 
Metastases to gallbladder * 1  1/3304 (0.03%) 
Metastases to lung * 1  1/3304 (0.03%) 
Ovarian cancer * 1  1/3304 (0.03%) 
Pancreatic carcinoma * 1  2/3304 (0.06%) 
Plasma cell leukaemia * 1  1/3304 (0.03%) 
Plasma cell myeloma * 1  1/3304 (0.03%) 
POEMS syndrome * 1  1/3304 (0.03%) 
Uterine cancer * 1  2/3304 (0.06%) 
Uterine leiomyoma * 1  2/3304 (0.06%) 
Nervous system disorders   
Altered state of consciousness * 1  3/3304 (0.09%) 
Cerebral haemorrhage * 1  8/3304 (0.24%) 
Cerebral infarction * 1  9/3304 (0.27%) 
Clonic convulsion * 1  1/3304 (0.03%) 
Dementia * 1  1/3304 (0.03%) 
Dizziness * 1  2/3304 (0.06%) 
Embolic stroke * 1  2/3304 (0.06%) 
Febrile convulsion * 1  1/3304 (0.03%) 
Haemorrhagic cerebral infarction * 1  1/3304 (0.03%) 
Headache * 1  1/3304 (0.03%) 
Hepatic encephalopathy * 1  1/3304 (0.03%) 
Hypoxic-ischaemic encephalopathy * 1  5/3304 (0.15%) 
Intracranial pressure increased * 1  1/3304 (0.03%) 
Lacunar infarction * 1  1/3304 (0.03%) 
Loss of consciousness * 1  3/3304 (0.09%) 
Neuropsychiatric lupus * 1  1/3304 (0.03%) 
Seizure * 1  1/3304 (0.03%) 
Seizure anoxic * 1  1/3304 (0.03%) 
Spastic paralysis * 1  1/3304 (0.03%) 
Status epilepticus * 1  3/3304 (0.09%) 
Subarachnoid haemorrhage * 1  1/3304 (0.03%) 
Syncope * 1  5/3304 (0.15%) 
Tremor * 1  1/3304 (0.03%) 
VIIth nerve paralysis * 1  1/3304 (0.03%) 
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous * 1  2/3304 (0.06%) 
Blighted ovum * 1  1/3304 (0.03%) 
Retained placenta or membranes * 1  1/3304 (0.03%) 
Psychiatric disorders   
Aggression * 1  1/3304 (0.03%) 
Depression * 1  3/3304 (0.09%) 
Disorientation * 1  1/3304 (0.03%) 
Restlessness * 1  2/3304 (0.06%) 
Self injurious behaviour * 1  1/3304 (0.03%) 
Substance-induced psychotic disorder * 1  1/3304 (0.03%) 
Renal and urinary disorders   
Acute kidney injury * 1  12/3304 (0.36%) 
Acute prerenal failure * 1  1/3304 (0.03%) 
Azotaemia * 1  1/3304 (0.03%) 
Calculus urinary * 1  1/3304 (0.03%) 
Chronic kidney disease * 1  4/3304 (0.12%) 
Diabetic nephropathy * 1  1/3304 (0.03%) 
Prerenal failure * 1  3/3304 (0.09%) 
Renal disorder * 1  2/3304 (0.06%) 
Renal failure * 1  15/3304 (0.45%) 
Renal impairment * 1  8/3304 (0.24%) 
Scleroderma renal crisis * 1  1/3304 (0.03%) 
Reproductive system and breast disorders   
Cervical dysplasia * 1  1/3304 (0.03%) 
Menorrhagia * 1  1/3304 (0.03%) 
Metrorrhagia * 1  2/3304 (0.06%) 
Respiratory, thoracic and mediastinal disorders   
Acute pulmonary oedema * 1  2/3304 (0.06%) 
Acute respiratory distress syndrome * 1  1/3304 (0.03%) 
Acute respiratory failure * 1  5/3304 (0.15%) 
Aspiration * 1  1/3304 (0.03%) 
Asthma * 1  7/3304 (0.21%) 
Atelectasis * 1  3/3304 (0.09%) 
Bronchiectasis * 1  1/3304 (0.03%) 
Bronchopulmonary dysplasia * 1  2/3304 (0.06%) 
Chronic obstructive pulmonary disease * 1  2/3304 (0.06%) 
Chronic respiratory failure * 1  5/3304 (0.15%) 
Chylothorax * 1  2/3304 (0.06%) 
Cough * 1  1/3304 (0.03%) 
Diffuse panbronchiolitis * 1  1/3304 (0.03%) 
Dyspnoea * 1  10/3304 (0.30%) 
Dyspnoea exertional * 1  1/3304 (0.03%) 
Emphysema * 1  2/3304 (0.06%) 
Epistaxis * 1  2/3304 (0.06%) 
Fibrinous bronchitis * 1  1/3304 (0.03%) 
Haemoptysis * 1  21/3304 (0.64%) 
Hypercapnia * 1  2/3304 (0.06%) 
Hypoxia * 1  14/3304 (0.42%) 
Idiopathic pulmonary fibrosis * 1  6/3304 (0.18%) 
Interstitial lung disease * 1  67/3304 (2.03%) 
Laryngeal oedema * 1  1/3304 (0.03%) 
Lung disorder * 1  5/3304 (0.15%) 
Pleural effusion * 1  8/3304 (0.24%) 
Pleurisy * 1  1/3304 (0.03%) 
Pneumonia aspiration * 1  8/3304 (0.24%) 
Pneumothorax * 1  17/3304 (0.51%) 
Pneumothorax spontaneous * 1  2/3304 (0.06%) 
Pulmonary alveolar haemorrhage * 1  6/3304 (0.18%) 
Pulmonary arterial hypertension * 1  10/3304 (0.30%) 
Pulmonary congestion * 1  1/3304 (0.03%) 
Pulmonary embolism * 1  4/3304 (0.12%) 
Pulmonary fibrosis * 1  7/3304 (0.21%) 
Pulmonary haemorrhage * 1  17/3304 (0.51%) 
Pulmonary haemosiderosis * 1  1/3304 (0.03%) 
Pulmonary hypertension * 1  112/3304 (3.39%) 
Pulmonary hypertensive crisis * 1  5/3304 (0.15%) 
Pulmonary oedema * 1  4/3304 (0.12%) 
Pulmonary thrombosis * 1  2/3304 (0.06%) 
Pulmonary vein occlusion * 1  2/3304 (0.06%) 
Pulmonary vein stenosis * 1  4/3304 (0.12%) 
Pulmonary veno-occlusive disease * 1  3/3304 (0.09%) 
Respiratory arrest * 1  5/3304 (0.15%) 
Respiratory failure * 1  46/3304 (1.39%) 
Respiratory tract haemorrhage * 1  2/3304 (0.06%) 
Upper respiratory tract inflammation * 1  2/3304 (0.06%) 
Skin and subcutaneous tissue disorders   
Decubitus ulcer * 1  1/3304 (0.03%) 
Dermatitis exfoliative * 1  1/3304 (0.03%) 
Dermatomyositis * 1  1/3304 (0.03%) 
Drug eruption * 1  1/3304 (0.03%) 
Erythema * 1  1/3304 (0.03%) 
Haemorrhage subepidermal * 1  1/3304 (0.03%) 
Pruritus * 1  1/3304 (0.03%) 
Pruritus generalised * 1  1/3304 (0.03%) 
Rash * 1  1/3304 (0.03%) 
Skin ulcer * 1  2/3304 (0.06%) 
Stevens-Johnson syndrome * 1  1/3304 (0.03%) 
Telangiectasia * 1  1/3304 (0.03%) 
Toxic skin eruption * 1  2/3304 (0.06%) 
Urticaria * 1  1/3304 (0.03%) 
Surgical and medical procedures   
Catheter removal * 1  1/3304 (0.03%) 
Lung transplant * 1  1/3304 (0.03%) 
Skin operation * 1  1/3304 (0.03%) 
Vascular disorders   
Arteriovenous fistula * 1  1/3304 (0.03%) 
Circulatory collapse * 1  13/3304 (0.39%) 
Deep vein thrombosis * 1  2/3304 (0.06%) 
Haematoma * 1  1/3304 (0.03%) 
Haemorrhage * 1  3/3304 (0.09%) 
Hypertension * 1  2/3304 (0.06%) 
Hypotension * 1  10/3304 (0.30%) 
Kawasaki's disease * 1  1/3304 (0.03%) 
Orthostatic hypotension * 1  1/3304 (0.03%) 
Shock * 1  8/3304 (0.24%) 
Shock haemorrhagic * 1  2/3304 (0.06%) 
Vena cava thrombosis * 1  1/3304 (0.03%) 
Venous thrombosis limb * 1  1/3304 (0.03%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.0%
Revatio (Sildenafil Citrate)
Affected / at Risk (%)
Total   509/3304 (15.41%) 
Blood and lymphatic system disorders   
Anaemia * 1  74/3304 (2.24%) 
Gastrointestinal disorders   
Diarrhoea * 1  79/3304 (2.39%) 
Hepatobiliary disorders   
Hepatic function abnormal * 1  67/3304 (2.03%) 
Infections and infestations   
Bronchitis * 1  82/3304 (2.48%) 
Nervous system disorders   
Headache * 1  136/3304 (4.12%) 
Respiratory, thoracic and mediastinal disorders   
Upper respiratory tract inflammation * 1  71/3304 (2.15%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00666198     History of Changes
Other Study ID Numbers: A1481263
First Submitted: April 22, 2008
First Posted: April 24, 2008
Results First Submitted: February 28, 2017
Results First Posted: April 24, 2017
Last Update Posted: April 24, 2017