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Trial record 15 of 51 for:    "Invasive Aspergillosis" | "Anti-Infective Agents"

A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children

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ClinicalTrials.gov Identifier: NCT00836875
Recruitment Status : Terminated (This protocol terminated prematurely on July 8, 2013 due to slow enrollment, not because of any safety issues or concerns.)
First Posted : February 4, 2009
Results First Posted : June 23, 2014
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Invasive Aspergillosis
Intervention Drug: Voriconazole
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Voriconazole: 2 to <12 Years Voriconazole: 12 to <18 Years
Hide Arm/Group Description Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg. Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
Period Title: Overall Study
Started 11 20
Completed 8 17
Not Completed 3 3
Reason Not Completed
Death             3             2
Withdrawal by Subject             0             1
Arm/Group Title Voriconazole: 2 to <12 Years Voriconazole: 12 to <18 Years Total
Hide Arm/Group Description Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg. Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h. Total of all reporting groups
Overall Number of Baseline Participants 11 20 31
Hide Baseline Analysis Population Description
Safety population: included all participants who received at least 1 dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 20 participants 31 participants
7.9  (2.3) 14.1  (1.7) 11.9  (3.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 20 participants 31 participants
Female
4
  36.4%
11
  55.0%
15
  48.4%
Male
7
  63.6%
9
  45.0%
16
  51.6%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description [Not Specified]
Time Frame Baseline, daily while hospitalized, Days 7, 14, 28, 42, 84, and 114, at end of treatment, and up to 1 month post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Voriconazole: 2 to <12 Years Voriconazole: 12 to <18 Years
Hide Arm/Group Description:
Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
Overall Number of Participants Analyzed 11 20
Measure Type: Number
Unit of Measure: participants
With AEs 11 19
With serious AEs 6 9
With severe AEs 5 8
Discontinued treatment due to AEs 1 0
Dose reduced or temporarily discontinued due to AE 0 4
2.Secondary Outcome
Title Percentage of Participants With a Global Response of Success
Hide Description Percentage of participants with global response of success at Weeks 6 and at EOT (up to Week 12). Global response of success was defined as a participant who achieved a complete or partial global response per the investigator. Complete response was defined as resolution of all clinical signs and symptoms PLUS resolution of 90 percent (%) or more of the lesions visible on radiological studies and attributed to invasive aspergillosis (IA) at Baseline. Partial response was defined as clinical improvement PLUS 50% to <90% resolution of the radiological lesions attributed to IA at Baseline.
Time Frame Weeks 6 and End of Treatment (EOT; up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (MITT) population: all participants receiving at least 1 dose of study drug and diagnosed with proven or probable aspergillosis (defined by modified European Organization for Research and Treatment of Cancer Mycoses Study Group [EORTC/MSC] criteria) or microbiologically confirmed scedosporium or fusarium infection.
Arm/Group Title Voriconazole: 2 to <12 Years Voriconazole: 12 to <18 Years
Hide Arm/Group Description:
Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
Overall Number of Participants Analyzed 5 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 6
40.0
(5.3 to 85.3)
77.8
(40.0 to 97.2)
EOT
40.0
(5.3 to 85.3)
77.8
(40.0 to 97.2)
3.Secondary Outcome
Title All-Cause Mortality - Number of Participant Deaths
Hide Description Number of participant deaths reported at Week 6 and at EOT (up to Week 12).
Time Frame Week 6 and EOT (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Voriconazole: 2 to <12 Years Voriconazole: 12 to <18 Years
Hide Arm/Group Description:
Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
Overall Number of Participants Analyzed 11 20
Measure Type: Number
Unit of Measure: participants
Week 6 3 1
EOT 0 1
4.Secondary Outcome
Title Attributable Mortality - Number of Participant Deaths
Hide Description Number of participant deaths attributable to study drug reported at Week 6 and at EOT (up to Week 12).
Time Frame Weeks 6 and EOT (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Voriconazole: 2 to <12 Years Voriconazole: 12 to <18 Years
Hide Arm/Group Description:
Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
Overall Number of Participants Analyzed 11 20
Measure Type: Number
Unit of Measure: participants
0 0
5.Secondary Outcome
Title Time to Death
Hide Description [Not Specified]
Time Frame Baseline up to 1 month post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population; only participants who died were included in the analysis.
Arm/Group Title Voriconazole: 2 to <12 Years Voriconazole: 12 to <18 Years
Hide Arm/Group Description:
Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
Overall Number of Participants Analyzed 3 2
Median (Full Range)
Unit of Measure: days
30.0
(18 to 38)
47.5
(20 to 75)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). 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 Voriconazole: 2 to <12 Years Voriconazole: 12 to <18 Years
Hide Arm/Group Description Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg. Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
All-Cause Mortality
Voriconazole: 2 to <12 Years Voriconazole: 12 to <18 Years
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Voriconazole: 2 to <12 Years Voriconazole: 12 to <18 Years
Affected / at Risk (%) Affected / at Risk (%)
Total   6/11 (54.55%)   9/20 (45.00%) 
Blood and lymphatic system disorders     
Coagulopathy * 1  0/11 (0.00%)  1/20 (5.00%) 
Febrile neutropenia * 1  1/11 (9.09%)  2/20 (10.00%) 
Neutropenia * 1  1/11 (9.09%)  0/20 (0.00%) 
Thrombocytopenia * 1  0/11 (0.00%)  1/20 (5.00%) 
Cardiac disorders     
Cardiac arrest * 1  1/11 (9.09%)  0/20 (0.00%) 
Cardiac failure congestive * 1  0/11 (0.00%)  1/20 (5.00%) 
Eye disorders     
Visual impairment * 1  0/11 (0.00%)  1/20 (5.00%) 
Gastrointestinal disorders     
Gingival bleeding * 1  0/11 (0.00%)  1/20 (5.00%) 
Lower gastrointestinal haemorrhage * 1  1/11 (9.09%)  0/20 (0.00%) 
Small intestinal haemorrhage * 1  0/11 (0.00%)  1/20 (5.00%) 
Upper gastrointestinal haemorrhage * 1  0/11 (0.00%)  1/20 (5.00%) 
Hepatobiliary disorders     
Drug-induced liver injury * 1  0/11 (0.00%)  1/20 (5.00%) 
Infections and infestations     
Aspergillosis * 1  1/11 (9.09%)  0/20 (0.00%) 
Pneumonia * 1  0/11 (0.00%)  1/20 (5.00%) 
Sepsis * 1  1/11 (9.09%)  1/20 (5.00%) 
Septic shock * 1  2/11 (18.18%)  2/20 (10.00%) 
Metabolism and nutrition disorders     
Hypoglycaemia * 1  1/11 (9.09%)  0/20 (0.00%) 
Hypokalaemia * 1  1/11 (9.09%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness * 1  0/11 (0.00%)  1/20 (5.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute lymphocytic leukaemia * 1  0/11 (0.00%)  2/20 (10.00%) 
Nervous system disorders     
Loss of consciousness * 1  0/11 (0.00%)  1/20 (5.00%) 
Renal and urinary disorders     
Renal failure acute * 1  1/11 (9.09%)  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion * 1  0/11 (0.00%)  1/20 (5.00%) 
Pulmonary oedema * 1  0/11 (0.00%)  1/20 (5.00%) 
Respiratory failure * 1  0/11 (0.00%)  1/20 (5.00%) 
Surgical and medical procedures     
Endotracheal intubation * 1  0/11 (0.00%)  1/20 (5.00%) 
Vascular disorders     
Aneurysm ruptured * 1  1/11 (9.09%)  0/20 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Voriconazole: 2 to <12 Years Voriconazole: 12 to <18 Years
Affected / at Risk (%) Affected / at Risk (%)
Total   10/11 (90.91%)   19/20 (95.00%) 
Blood and lymphatic system disorders     
Disseminated intravascular coagulation * 1  0/11 (0.00%)  1/20 (5.00%) 
Febrile neutropenia * 1  0/11 (0.00%)  2/20 (10.00%) 
Lymphadenitis * 1  1/11 (9.09%)  0/20 (0.00%) 
Lymphopenia * 1  0/11 (0.00%)  1/20 (5.00%) 
Neutropenia * 1  1/11 (9.09%)  0/20 (0.00%) 
Neutrophilia * 1  0/11 (0.00%)  1/20 (5.00%) 
Pancytopenia * 1  1/11 (9.09%)  0/20 (0.00%) 
Thrombocytopenia * 1  1/11 (9.09%)  2/20 (10.00%) 
Cardiac disorders     
Tachycardia * 1  0/11 (0.00%)  1/20 (5.00%) 
Ear and labyrinth disorders     
Ear haemorrhage * 1  1/11 (9.09%)  0/20 (0.00%) 
Tinnitus * 1  0/11 (0.00%)  1/20 (5.00%) 
Eye disorders     
Abnormal sensation in eye * 1  0/11 (0.00%)  1/20 (5.00%) 
Asthenopia * 1  0/11 (0.00%)  1/20 (5.00%) 
Cataract * 1  0/11 (0.00%)  1/20 (5.00%) 
Chromatopsia * 1  0/11 (0.00%)  1/20 (5.00%) 
Conjunctival haemorrhage * 1  1/11 (9.09%)  0/20 (0.00%) 
Conjunctivitis * 1  0/11 (0.00%)  2/20 (10.00%) 
Diplopia * 1  0/11 (0.00%)  1/20 (5.00%) 
Dry eye * 1  1/11 (9.09%)  0/20 (0.00%) 
Eye discharge * 1  1/11 (9.09%)  0/20 (0.00%) 
Eye irritation * 1  0/11 (0.00%)  1/20 (5.00%) 
Eye pain * 1  0/11 (0.00%)  1/20 (5.00%) 
Photophobia * 1  1/11 (9.09%)  1/20 (5.00%) 
Vision blurred * 1  0/11 (0.00%)  3/20 (15.00%) 
Visual impairment * 1  0/11 (0.00%)  1/20 (5.00%) 
Gastrointestinal disorders     
Abdominal distension * 1  0/11 (0.00%)  1/20 (5.00%) 
Abdominal pain * 1  0/11 (0.00%)  3/20 (15.00%) 
Abdominal pain upper * 1  0/11 (0.00%)  1/20 (5.00%) 
Anal fissure * 1  0/11 (0.00%)  1/20 (5.00%) 
Constipation * 1  1/11 (9.09%)  1/20 (5.00%) 
Diarrhoea * 1  3/11 (27.27%)  1/20 (5.00%) 
Dysphagia * 1  0/11 (0.00%)  1/20 (5.00%) 
Flatulence * 1  0/11 (0.00%)  1/20 (5.00%) 
Gastritis * 1  0/11 (0.00%)  1/20 (5.00%) 
Gastrooesophageal reflux disease * 1  0/11 (0.00%)  1/20 (5.00%) 
Haematemesis * 1  0/11 (0.00%)  1/20 (5.00%) 
Lip dry * 1  1/11 (9.09%)  0/20 (0.00%) 
Mouth haemorrhage * 1  1/11 (9.09%)  1/20 (5.00%) 
Mouth ulceration * 1  1/11 (9.09%)  2/20 (10.00%) 
Nausea * 1  0/11 (0.00%)  2/20 (10.00%) 
Painful defaecation * 1  1/11 (9.09%)  0/20 (0.00%) 
Proctalgia * 1  1/11 (9.09%)  0/20 (0.00%) 
Rectal haemorrhage * 1  0/11 (0.00%)  1/20 (5.00%) 
Upper gastrointestinal haemorrhage * 1  1/11 (9.09%)  0/20 (0.00%) 
Vomiting * 1  1/11 (9.09%)  1/20 (5.00%) 
General disorders     
Catheter site discharge * 1  0/11 (0.00%)  1/20 (5.00%) 
Catheter site pain * 1  1/11 (9.09%)  2/20 (10.00%) 
Fatigue * 1  0/11 (0.00%)  1/20 (5.00%) 
Infusion site pain * 1  0/11 (0.00%)  1/20 (5.00%) 
Local swelling * 1  0/11 (0.00%)  1/20 (5.00%) 
Mucosal inflammation * 1  0/11 (0.00%)  3/20 (15.00%) 
Oedema peripheral * 1  0/11 (0.00%)  2/20 (10.00%) 
Pain * 1  0/11 (0.00%)  2/20 (10.00%) 
Pyrexia * 1  0/11 (0.00%)  7/20 (35.00%) 
Hepatobiliary disorders     
Jaundice cholestatic * 1  0/11 (0.00%)  1/20 (5.00%) 
Infections and infestations     
Anal abscess * 1  0/11 (0.00%)  1/20 (5.00%) 
Bacteraemia * 1  0/11 (0.00%)  1/20 (5.00%) 
Bronchitis * 1  0/11 (0.00%)  1/20 (5.00%) 
Cytomegalovirus infection * 1  1/11 (9.09%)  0/20 (0.00%) 
Device related infection * 1  0/11 (0.00%)  1/20 (5.00%) 
Implant site pustules * 1  1/11 (9.09%)  0/20 (0.00%) 
Paronychia * 1  0/11 (0.00%)  1/20 (5.00%) 
Postoperative wound infection * 1  1/11 (9.09%)  0/20 (0.00%) 
Sinusitis * 1  0/11 (0.00%)  2/20 (10.00%) 
Staphylococcal bacteraemia * 1  0/11 (0.00%)  1/20 (5.00%) 
Staphylococcal infection * 1  0/11 (0.00%)  1/20 (5.00%) 
Systemic candida * 1  0/11 (0.00%)  1/20 (5.00%) 
Upper respiratory tract infection * 1  3/11 (27.27%)  1/20 (5.00%) 
Viral upper respiratory tract infection * 1  0/11 (0.00%)  1/20 (5.00%) 
Injury, poisoning and procedural complications     
Allergic transfusion reaction * 1  1/11 (9.09%)  1/20 (5.00%) 
Contusion * 1  0/11 (0.00%)  2/20 (10.00%) 
Excoriation * 1  0/11 (0.00%)  2/20 (10.00%) 
Incorrect drug administration rate * 1  1/11 (9.09%)  0/20 (0.00%) 
Procedural pain * 1  2/11 (18.18%)  2/20 (10.00%) 
Investigations     
Activated partial thromboplastin time prolonged * 1  1/11 (9.09%)  0/20 (0.00%) 
Alanine aminotransferase increased * 1  0/11 (0.00%)  2/20 (10.00%) 
Aspartate aminotransferase increased * 1  0/11 (0.00%)  1/20 (5.00%) 
Blood bilirubin increased * 1  0/11 (0.00%)  1/20 (5.00%) 
Blood creatinine increased * 1  1/11 (9.09%)  1/20 (5.00%) 
Blood phosphorus decreased * 1  1/11 (9.09%)  0/20 (0.00%) 
Blood potassium increased * 1  0/11 (0.00%)  1/20 (5.00%) 
Blood pressure increased * 1  0/11 (0.00%)  1/20 (5.00%) 
Blood uric acid increased * 1  0/11 (0.00%)  1/20 (5.00%) 
Cardiac murmur * 1  1/11 (9.09%)  0/20 (0.00%) 
Liver function test abnormal * 1  0/11 (0.00%)  2/20 (10.00%) 
Oxygen saturation decreased * 1  0/11 (0.00%)  1/20 (5.00%) 
Prothrombin time prolonged * 1  1/11 (9.09%)  0/20 (0.00%) 
Respirovirus test positive * 1  0/11 (0.00%)  1/20 (5.00%) 
Transaminases increased * 1  0/11 (0.00%)  2/20 (10.00%) 
Weight decreased * 1  0/11 (0.00%)  1/20 (5.00%) 
Metabolism and nutrition disorders     
Fluid overload * 1  0/11 (0.00%)  1/20 (5.00%) 
Fluid retention * 1  0/11 (0.00%)  1/20 (5.00%) 
Hypercalcaemia * 1  0/11 (0.00%)  1/20 (5.00%) 
Hyperkalaemia * 1  0/11 (0.00%)  2/20 (10.00%) 
Hyperuricaemia * 1  0/11 (0.00%)  1/20 (5.00%) 
Hypoalbuminaemia * 1  1/11 (9.09%)  1/20 (5.00%) 
Hypocalcaemia * 1  3/11 (27.27%)  0/20 (0.00%) 
Hypokalaemia * 1  1/11 (9.09%)  3/20 (15.00%) 
Hypomagnesaemia * 1  2/11 (18.18%)  1/20 (5.00%) 
Hyponatraemia * 1  2/11 (18.18%)  0/20 (0.00%) 
Hypophosphataemia * 1  3/11 (27.27%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/11 (9.09%)  0/20 (0.00%) 
Back pain * 1  0/11 (0.00%)  3/20 (15.00%) 
Muscle spasms * 1  0/11 (0.00%)  1/20 (5.00%) 
Myalgia * 1  1/11 (9.09%)  1/20 (5.00%) 
Neck pain * 1  0/11 (0.00%)  1/20 (5.00%) 
Pain in extremity * 1  1/11 (9.09%)  2/20 (10.00%) 
Pain in jaw * 1  1/11 (9.09%)  0/20 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Leukaemia * 1  0/11 (0.00%)  1/20 (5.00%) 
Nervous system disorders     
Central nervous system lesion * 1  0/11 (0.00%)  1/20 (5.00%) 
Dizziness * 1  0/11 (0.00%)  3/20 (15.00%) 
Headache * 1  1/11 (9.09%)  2/20 (10.00%) 
Lethargy * 1  0/11 (0.00%)  2/20 (10.00%) 
Paraesthesia * 1  0/11 (0.00%)  1/20 (5.00%) 
Somnolence * 1  0/11 (0.00%)  1/20 (5.00%) 
Psychiatric disorders     
Affect lability * 1  0/11 (0.00%)  1/20 (5.00%) 
Depression * 1  1/11 (9.09%)  0/20 (0.00%) 
Insomnia * 1  0/11 (0.00%)  2/20 (10.00%) 
Renal and urinary disorders     
Dysuria * 1  0/11 (0.00%)  1/20 (5.00%) 
Pollakiuria * 1  0/11 (0.00%)  1/20 (5.00%) 
Renal failure * 1  0/11 (0.00%)  1/20 (5.00%) 
Urinary retention * 1  0/11 (0.00%)  1/20 (5.00%) 
Reproductive system and breast disorders     
Genital swelling * 1  1/11 (9.09%)  0/20 (0.00%) 
Vulvar erosion * 1  1/11 (9.09%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchospasm * 1  0/11 (0.00%)  1/20 (5.00%) 
Cough * 1  2/11 (18.18%)  2/20 (10.00%) 
Dyspnoea * 1  0/11 (0.00%)  2/20 (10.00%) 
Epistaxis * 1  2/11 (18.18%)  4/20 (20.00%) 
Haemoptysis * 1  0/11 (0.00%)  1/20 (5.00%) 
Hypoxia * 1  0/11 (0.00%)  1/20 (5.00%) 
Nasal congestion * 1  1/11 (9.09%)  2/20 (10.00%) 
Oropharyngeal pain * 1  0/11 (0.00%)  2/20 (10.00%) 
Pharyngeal inflammation * 1  0/11 (0.00%)  1/20 (5.00%) 
Rales * 1  1/11 (9.09%)  0/20 (0.00%) 
Tachypnoea * 1  0/11 (0.00%)  2/20 (10.00%) 
Skin and subcutaneous tissue disorders     
Decubitus ulcer * 1  1/11 (9.09%)  0/20 (0.00%) 
Dermatitis allergic * 1  1/11 (9.09%)  0/20 (0.00%) 
Dermatitis contact * 1  1/11 (9.09%)  0/20 (0.00%) 
Dermatitis exfoliative * 1  0/11 (0.00%)  1/20 (5.00%) 
Dry skin * 1  0/11 (0.00%)  1/20 (5.00%) 
Ecchymosis * 1  1/11 (9.09%)  0/20 (0.00%) 
Erythema * 1  0/11 (0.00%)  1/20 (5.00%) 
Heat rash * 1  0/11 (0.00%)  1/20 (5.00%) 
Hyperhidrosis * 1  1/11 (9.09%)  0/20 (0.00%) 
Ingrowing nail * 1  0/11 (0.00%)  1/20 (5.00%) 
Petechiae * 1  0/11 (0.00%)  1/20 (5.00%) 
Pigmentation disorder * 1  0/11 (0.00%)  1/20 (5.00%) 
Post inflammatory pigmentation change * 1  1/11 (9.09%)  0/20 (0.00%) 
Pruritus * 1  0/11 (0.00%)  1/20 (5.00%) 
Rash * 1  0/11 (0.00%)  1/20 (5.00%) 
Rash macular * 1  1/11 (9.09%)  1/20 (5.00%) 
Rash maculo-papular * 1  2/11 (18.18%)  1/20 (5.00%) 
Red man syndrome * 1  1/11 (9.09%)  0/20 (0.00%) 
Scab * 1  0/11 (0.00%)  1/20 (5.00%) 
Skin burning sensation * 1  1/11 (9.09%)  0/20 (0.00%) 
Skin lesion * 1  1/11 (9.09%)  0/20 (0.00%) 
Toxic skin eruption * 1  1/11 (9.09%)  0/20 (0.00%) 
Urticaria * 1  0/11 (0.00%)  1/20 (5.00%) 
Vascular disorders     
Flushing * 1  0/11 (0.00%)  1/20 (5.00%) 
Haematoma * 1  0/11 (0.00%)  1/20 (5.00%) 
Haemorrhage * 1  0/11 (0.00%)  1/20 (5.00%) 
Hypertension * 1  0/11 (0.00%)  1/20 (5.00%) 
Hypotension * 1  0/11 (0.00%)  1/20 (5.00%) 
Phlebitis * 1  0/11 (0.00%)  1/20 (5.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
The study was prematurely terminated due to slow enrollment. The study was not terminated due to any safety issues or concerns. Interpretation of the data are limited due to the small sample size and descriptive design.
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
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00836875     History of Changes
Other Study ID Numbers: A1501080
2008-005275-10 ( EudraCT Number )
First Submitted: February 3, 2009
First Posted: February 4, 2009
Results First Submitted: May 9, 2014
Results First Posted: June 23, 2014
Last Update Posted: June 16, 2017