Trial Outcomes & Findings for Open, Non Comparative Study Of Voriconazole In Slovak Patients With Very High Risk Of Developing An Invasive Fungal Infection (NCT NCT01137292)
NCT ID: NCT01137292
Last Updated: 2011-09-02
Results Overview
Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, and no mycological culture performed. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines.
Recruitment status
COMPLETED
Target enrollment
177 participants
Primary outcome timeframe
up to 2 weeks (EOT visit)
Results posted on
2011-09-02
Participant Flow
Participant milestones
| Measure |
Voriconazole
In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of \>40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.
Adults with a weight of \<40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age.
|
|---|---|
|
Overall Study
STARTED
|
177
|
|
Overall Study
COMPLETED
|
123
|
|
Overall Study
NOT COMPLETED
|
54
|
Reasons for withdrawal
| Measure |
Voriconazole
In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of \>40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.
Adults with a weight of \<40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age.
|
|---|---|
|
Overall Study
Death
|
30
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lack of Efficacy
|
13
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Other
|
7
|
Baseline Characteristics
Open, Non Comparative Study Of Voriconazole In Slovak Patients With Very High Risk Of Developing An Invasive Fungal Infection
Baseline characteristics by cohort
| Measure |
Voriconazole
n=177 Participants
In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of \>40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.
Adults with a weight of \<40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age.
|
|---|---|
|
Age, Customized
< 2 years
|
3 participants
n=5 Participants
|
|
Age, Customized
2 to 18 years
|
16 participants
n=5 Participants
|
|
Age, Customized
19 to 44 years
|
52 participants
n=5 Participants
|
|
Age, Customized
45 to 64 years
|
80 participants
n=5 Participants
|
|
Age, Customized
> = 65 years
|
26 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
|
Number of Participants Having Certain Methods of Diagnosis of Invasive Aspergillosis
Hi-Resolution Computed Tomography
|
91 participants
n=5 Participants
|
|
Number of Participants Having Certain Methods of Diagnosis of Invasive Aspergillosis
Galactomannan
|
55 participants
n=5 Participants
|
|
Number of Participants Having Certain Methods of Diagnosis of Invasive Aspergillosis
Polymerase Chain Reaction (PCR)
|
5 participants
n=5 Participants
|
|
Number of Participants Having Certain Methods of Diagnosis of Invasive Aspergillosis
Blood Culture
|
8 participants
n=5 Participants
|
|
Number of Participants Having Certain Methods of Diagnosis of Invasive Aspergillosis
Bronchoalveolar Lavage (BAL)
|
23 participants
n=5 Participants
|
|
Number of Participants Having Certain Methods of Diagnosis of Invasive Aspergillosis
Biopsy
|
2 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Radiotherapy
|
8 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Neuropenia
|
104 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Autologic Bone Marrow Transplant
|
11 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Polytrauma
|
13 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Antibiotic Prophylaxis
|
81 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Immunosuppressive Treatment
|
42 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Graft-Versus-Host Disease
|
7 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Malignant Tumour
|
110 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Chemotherapy
|
122 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Undergone Surgery
|
23 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Central Venous Catether
|
110 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Ventilation (Intubation)
|
32 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Hemodialysis
|
5 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Antifungal Prophylaxis
|
114 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Primary/Secondary Immunodeficiency
|
101 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Total Parental Nutrition
|
35 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Cytomegalovirus Infection
|
13 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Allogenic Bone Marrow Transplant
|
13 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Diabetes Mellitus
|
10 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Organ Transplant
|
3 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Previous Antibiotic Treatment
|
120 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Steroid Treatment
|
74 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Mucositisis
|
38 participants
n=5 Participants
|
|
Number of Participants with Risk Factors of Invasive Fungal Infections
Other Invasive Mycosis
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 2 weeks (EOT visit)Population: Full Analysis Set (FAS) = all enrolled participants who were administered the study medication and had post baseline documentation of efficacy available.
Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, and no mycological culture performed. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines.
Outcome measures
| Measure |
Voriconazole
n=177 Participants
In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of \>40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.
Adults with a weight of \<40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age.
|
|---|---|
|
Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit
Clinical Cure
|
64 participants
|
|
Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit
Clinical Improvement
|
64 participants
|
|
Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit
No Clinical Cure
|
36 participants
|
|
Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit
No Mycological Cure
|
10 participants
|
|
Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit
No Mycological Culture Performed
|
40 participants
|
|
Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit
Mycological Cure
|
34 participants
|
PRIMARY outcome
Timeframe: more than 2 weeks (Test-of-Cure visit)Population: FAS.
Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, no mycological culture performed, death, and lost from follow-up. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines.
Outcome measures
| Measure |
Voriconazole
n=177 Participants
In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of \>40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.
Adults with a weight of \<40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age.
|
|---|---|
|
Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit
Clinical Cure
|
54 participants
|
|
Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit
Clinical Improvement
|
46 participants
|
|
Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit
No Clinical Cure
|
7 participants
|
|
Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit
Mycological Cure
|
31 participants
|
|
Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit
No Mycological Cure
|
1 participants
|
|
Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit
No Mycological Culture Performed
|
19 participants
|
|
Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit
Death
|
41 participants
|
|
Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit
Lost From Follow-Up
|
11 participants
|
PRIMARY outcome
Timeframe: up to 2 weeks (EOT visit)Population: FAS. Number or participants analyzed = Number of participants with Investigator's satisfaction response for the efficacy of voriconazole at the EOT Visit.
Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.
Outcome measures
| Measure |
Voriconazole
n=172 Participants
In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of \>40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.
Adults with a weight of \<40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age.
|
|---|---|
|
Number of Participants With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit
Moderate
|
33 participants
|
|
Number of Participants With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit
Poor
|
5 participants
|
|
Number of Participants With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit
Very Good
|
85 participants
|
|
Number of Participants With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit
Good
|
49 participants
|
PRIMARY outcome
Timeframe: up to 2 weeks (EOT visit)Population: FAS. Number or participants analyzed = Number of participants with Investigator's satisfaction response for the tolerability of voriconazole at the EOT Visit.
Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.
Outcome measures
| Measure |
Voriconazole
n=174 Participants
In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of \>40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.
Adults with a weight of \<40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age.
|
|---|---|
|
Number of Participants With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit
Very Good
|
105 participants
|
|
Number of Participants With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit
Good
|
61 participants
|
|
Number of Participants With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit
Moderate
|
8 participants
|
|
Number of Participants With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit
Poor
|
0 participants
|
Adverse Events
Voriconazole
Serious events: 34 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Voriconazole
n=177 participants at risk
In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of \>40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.
Adults with a weight of \<40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age.
|
|---|---|
|
Blood and lymphatic system disorders
Bone marrow disorder
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac failure
|
2.8%
5/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiopulmonary failure
|
2.3%
4/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Disease progression
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Multi-organ failure
|
4.5%
8/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Sudden death
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Aspergillosis
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
2.8%
5/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sepsis
|
2.3%
4/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Septic shock
|
1.1%
2/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
1.1%
2/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic leukaemia
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.7%
3/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Locked-in syndrome
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Crush syndrome
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.7%
3/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Voriconazole
n=177 participants at risk
In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of \>40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.
Adults with a weight of \<40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age.
|
|---|---|
|
Hepatobiliary disorders
Liver disorder
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Hypersensitivity
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Acrodermatitis
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertensive crisis
|
0.56%
1/177
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 one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
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