Trial Outcomes & Findings for Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT) (NCT NCT00289991)
NCT ID: NCT00289991
Last Updated: 2015-11-20
Results Overview
Percent of responders (by randomization strata) with success of antifungal prophylaxis at 180 days after allogeneic hematopoietic stem cell transplant (HSCT). Success: alive at Day 180 (Visit 9), had not developed a breakthrough proven or probable invasive fungal infection (IFI) by Visit 9, and received full course of study drug prophylaxis without interruption of greater than 14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 9, imputed as failure at Visit 9 (programmatically).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
489 participants
Primary outcome timeframe
Day 180 (Visit 9)
Results posted on
2015-11-20
Participant Flow
Subjects were stratified at the time of randomization by the following factors: conditioning regimen (myeloablative or non-myeloablative); relatedness of donor (matched/related or mismatched/unrelated).
Participant milestones
| Measure |
Voriconazole
Voriconazole (tablet or powder for oral suspension) loading dose regimen intravenous (IV) for first 24 hours: 6 milligrams per kilogram (mg/kg) of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) twice daily (BID) or 200 mg tablet or powder for oral suspension by mouth (PO) BID (subjects greater than or equal to \[≥\] 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects less than \[\<\] 40 kg body weight).
|
Itraconazole
Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
|
|---|---|---|
|
Overall Study
STARTED
|
234
|
255
|
|
Overall Study
COMPLETED
|
176
|
175
|
|
Overall Study
NOT COMPLETED
|
58
|
80
|
Reasons for withdrawal
| Measure |
Voriconazole
Voriconazole (tablet or powder for oral suspension) loading dose regimen intravenous (IV) for first 24 hours: 6 milligrams per kilogram (mg/kg) of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) twice daily (BID) or 200 mg tablet or powder for oral suspension by mouth (PO) BID (subjects greater than or equal to \[≥\] 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects less than \[\<\] 40 kg body weight).
|
Itraconazole
Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
|
|---|---|---|
|
Overall Study
Death
|
35
|
38
|
|
Overall Study
Adverse Event
|
15
|
13
|
|
Overall Study
Failure of prophylaxis
|
1
|
1
|
|
Overall Study
Fungal breakthrough infection
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
12
|
|
Overall Study
Other
|
5
|
14
|
Baseline Characteristics
Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)
Baseline characteristics by cohort
| Measure |
Voriconazole
n=234 Participants
Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects \< 40 kg body weight).
|
Itraconazole
n=255 Participants
Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
|
Total
n=489 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<18 years
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Age, Customized
Between 18 and 44 years
|
106 participants
n=5 Participants
|
119 participants
n=7 Participants
|
225 participants
n=5 Participants
|
|
Age, Customized
Between 45 and 64 years
|
104 participants
n=5 Participants
|
115 participants
n=7 Participants
|
219 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
15 participants
n=5 Participants
|
10 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
42.7 years
STANDARD_DEVIATION 14.6 • n=7 Participants
|
43.0 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
138 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
293 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 180 (Visit 9)Population: Modified Intent to Treat (MITT): primary analysis population; all randomized subjects: received at least 1 dose of randomized study drug and had allogeneic HSCT; data from 1 site excluded due to Good Clinical Practice (GCP) deviations; (n)=number of subjects with analyzable data at observation for voriconazole and itraconazole, respectively.
Percent of responders (by randomization strata) with success of antifungal prophylaxis at 180 days after allogeneic hematopoietic stem cell transplant (HSCT). Success: alive at Day 180 (Visit 9), had not developed a breakthrough proven or probable invasive fungal infection (IFI) by Visit 9, and received full course of study drug prophylaxis without interruption of greater than 14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 9, imputed as failure at Visit 9 (programmatically).
Outcome measures
| Measure |
Voriconazole
n=224 Participants
Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects \< 40 kg body weight).
|
Itraconazole
n=241 Participants
Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
|
|---|---|---|
|
Success at Day 180: Percent of Responders (Randomization Strata)
Myeloablative/mismatched unrelated (n=59, 58)
|
52.5 percent of participants
|
25.9 percent of participants
|
|
Success at Day 180: Percent of Responders (Randomization Strata)
Non-myeloablative/matched related (n=58, 57)
|
34.5 percent of participants
|
28.1 percent of participants
|
|
Success at Day 180: Percent of Responders (Randomization Strata)
Non-myeloablative/mismatched unrelated (n=41, 41)
|
46.3 percent of participants
|
26.8 percent of participants
|
|
Success at Day 180: Percent of Responders (Randomization Strata)
Myeloablative/matched related (n=66, 85)
|
59.1 percent of participants
|
44.7 percent of participants
|
SECONDARY outcome
Timeframe: Day 100 (Visit 7)Population: MITT; data from 1 site excluded due to GCP deviations; (n)=number of subjects with analyzable data at observation for voriconazole and itraconazole, respectively.
Percent of responders (by randomization strata) with success of antifungal prophylaxis at 100 days after allogeneic HSCT. Success defined as: alive at Day 100 (Visit 7), had not developed a breakthrough proven or probable IFI by Visit 7, and received full course of study drug prophylaxis without an interruption of \>14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 7, imputed as failure at Visit 7 (programmatically).
Outcome measures
| Measure |
Voriconazole
n=224 Participants
Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects \< 40 kg body weight).
|
Itraconazole
n=241 Participants
Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
|
|---|---|---|
|
Success at Day 100: Percent of Responders (Randomization Strata)
Myeloablative/mismatched unrelated (n=59, 58)
|
55.9 percent of participants
|
27.6 percent of participants
|
|
Success at Day 100: Percent of Responders (Randomization Strata)
Non-myeloablative/mismatched unrelated (n=41, 41)
|
48.8 percent of participants
|
36.6 percent of participants
|
|
Success at Day 100: Percent of Responders (Randomization Strata)
Myeloablative/matched related (n=66, 85)
|
65.2 percent of participants
|
50.6 percent of participants
|
|
Success at Day 100: Percent of Responders (Randomization Strata)
Non-myeloablative/matched related (n=58, 57)
|
43.1 percent of participants
|
38.6 percent of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 180 (Visit 9)Population: MITT; data from 1 site excluded due to GCP deviations. Analysis excludes additional data on IFIs that were only captured on European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) worksheets (not on Case Report Forms or in the database). Times were summarized only for subjects who experienced a breakthrough IFI.
Summary of time (in days) from start of prophylaxis to first recorded occurrence of breakthrough proven or probable IFI.
Outcome measures
| Measure |
Voriconazole
n=3 Participants
Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects \< 40 kg body weight).
|
Itraconazole
n=4 Participants
Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
|
|---|---|---|
|
Time to Breakthrough Invasive Fungal Infection (IFI)
|
119.0 days
95% Confidence Interval 28.58 • Interval 48.0 to 190.0
|
77.0 days
95% Confidence Interval 77.08 • Interval 0.0 to 199.6
|
SECONDARY outcome
Timeframe: Day 1 up to Day 100 (Visit 7) and Day 180 (Visit 9)Population: MITT; data from 1 site excluded due to GCP deviations. Analysis excludes additional data on IFIs that were only captured on EORTC/MSG worksheets (not on Case Report Forms or in the database).
Percent of subjects with occurrence of breakthrough IFI (proven or probable). Included all subjects in the MITT population.
Outcome measures
| Measure |
Voriconazole
n=224 Participants
Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects \< 40 kg body weight).
|
Itraconazole
n=241 Participants
Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
|
|---|---|---|
|
Percent of Subjects With Occurrence of Breakthrough IFI
Day 100
|
0.9 percent of participants
|
1.2 percent of participants
|
|
Percent of Subjects With Occurrence of Breakthrough IFI
Day 180
|
1.3 percent of participants
|
1.7 percent of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 180 (Visit 9)Population: MITT; data from 1 site excluded due to GCP deviations. Analysis does not include any deaths recorded in the long-term follow-up data (not available at time of analysis).
Percent of subjects who died at or before Day 180, derived from the crude death rate. All subjects in the MITT population included in this proportion.
Outcome measures
| Measure |
Voriconazole
n=224 Participants
Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects \< 40 kg body weight).
|
Itraconazole
n=241 Participants
Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
|
|---|---|---|
|
Survival: Percent of Subjects Who Died at or Before Day 180
|
15.6 percent of participants
|
15.4 percent of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 180 (Visit 9)Population: MITT; data from 1 site excluded due to GCP deviations.
Time in days to discontinuation of study treatment defined as the number of days from first dose to last dose inclusive as recorded in the dosing log.
Outcome measures
| Measure |
Voriconazole
n=224 Participants
Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects \< 40 kg body weight).
|
Itraconazole
n=241 Participants
Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
|
|---|---|---|
|
Time to Discontinuation of Study Treatment
|
88.7 days
95% Confidence Interval 61.41 • Interval 80.6 to 96.8
|
71.5 days
95% Confidence Interval 52.21 • Interval 64.9 to 78.2
|
SECONDARY outcome
Timeframe: Day 1 up to 1 year (Day 365)Population: MITT; data from 1 site excluded due to GCP deviations. Typically, subjects received first dose study treatment on the day of their transplant; however, some subjects started treatment up to 48 hours after transplant. Data summarized with first day of study medication defined as Day 1.
Percent of subjects who died within 1 year after transplant, derived from the crude death rate. All subjects in the MITT population included in this proportion. Only deaths up until and including 365 days after first dose of study medication included in the analysis.
Outcome measures
| Measure |
Voriconazole
n=224 Participants
Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects \< 40 kg body weight).
|
Itraconazole
n=241 Participants
Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
|
|---|---|---|
|
Survival: Percent of Subjects Who Died Within 1 Year
|
25.9 percent of participants
|
30.7 percent of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 180Population: MITT; data from 1 site excluded due to GCP deviations.
Median duration in days of treatment. Treatment is defined as the total number of days on which subjects took medication.
Outcome measures
| Measure |
Voriconazole
n=224 Participants
Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects \< 40 kg body weight).
|
Itraconazole
n=241 Participants
Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
|
|---|---|---|
|
Duration of Treatment
|
96.0 days
Interval 1.0 to 258.0
|
68.0 days
Interval 3.0 to 223.0
|
SECONDARY outcome
Timeframe: Day 1 up to Day 180Population: MITT; data from 1 site excluded due to GCP deviations. Subjects who developed a breakthrough proven or probable IFI were identified only from the study database, not the EORTC/MSG worksheet. In addition, all agents identified to be antifungals were considered to be systemic.
Percent of subjects who used other systemic antifungal agents as empirical or therapeutic treatment, defined as either empirical: subject took a systemic antifungal agent at any time after the day of first dose of medication and did not develop a breakthrough proven or probable IFI during the study or therapeutic: subject developed a breakthrough proven or probable IFI.
Outcome measures
| Measure |
Voriconazole
n=224 Participants
Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects \< 40 kg body weight).
|
Itraconazole
n=241 Participants
Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
|
|---|---|---|
|
Percent of Subjects With Use of Other Systemic Antifungal Agents as Empirical or Therapeutic Treatment
|
40.6 percent of participants
|
49.4 percent of participants
|
Adverse Events
Voriconazole
Serious events: 111 serious events
Other events: 228 other events
Deaths: 0 deaths
Itraconazole
Serious events: 95 serious events
Other events: 252 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Voriconazole
n=234 participants at risk
Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects \< 40 kg body weight).
|
Itraconazole
n=255 participants at risk
Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.43%
1/234
|
0.00%
0/255
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/234
|
0.39%
1/255
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.3%
3/234
|
0.78%
2/255
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.43%
1/234
|
0.00%
0/255
|
|
Blood and lymphatic system disorders
Autoimmune thrombocytopenia
|
0.43%
1/234
|
0.00%
0/255
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.43%
1/234
|
0.00%
0/255
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.85%
2/234
|
1.6%
4/255
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.43%
1/234
|
0.00%
0/255
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.43%
1/234
|
0.00%
0/255
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.43%
1/234
|
0.00%
0/255
|
|
Cardiac disorders
Tachycardia
|
0.43%
1/234
|
0.00%
0/255
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/234
|
0.39%
1/255
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/234
|
0.39%
1/255
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.43%
1/234
|
0.00%
0/255
|
|
Eye disorders
Photopsia
|
0.43%
1/234
|
0.00%
0/255
|
|
Eye disorders
Vision blurred
|
0.00%
0/234
|
0.39%
1/255
|
|
Gastrointestinal disorders
Disbacteriosis
|
0.00%
0/234
|
0.39%
1/255
|
|
Gastrointestinal disorders
Caecitis
|
0.00%
0/234
|
0.39%
1/255
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/234
|
0.39%
1/255
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/234
|
0.39%
1/255
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
8/234
|
3.5%
9/255
|
|
Gastrointestinal disorders
Abdominal pain
|
0.43%
1/234
|
0.78%
2/255
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.43%
1/234
|
0.00%
0/255
|
|
Gastrointestinal disorders
Nausea
|
0.85%
2/234
|
2.4%
6/255
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/234
|
0.39%
1/255
|
|
Gastrointestinal disorders
Vomiting
|
0.43%
1/234
|
2.7%
7/255
|
|
Gastrointestinal disorders
Ileus
|
0.43%
1/234
|
0.00%
0/255
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/234
|
0.39%
1/255
|
|
General disorders
Hyperthermia
|
0.43%
1/234
|
0.00%
0/255
|
|
General disorders
Pyrexia
|
8.1%
19/234
|
4.3%
11/255
|
|
General disorders
Asthenia
|
0.00%
0/234
|
0.39%
1/255
|
|
General disorders
Chest pain
|
0.00%
0/234
|
0.39%
1/255
|
|
General disorders
Chills
|
0.43%
1/234
|
0.00%
0/255
|
|
General disorders
Disease progression
|
0.43%
1/234
|
0.39%
1/255
|
|
General disorders
Fatigue
|
0.00%
0/234
|
0.78%
2/255
|
|
General disorders
General physical health deterioration
|
0.00%
0/234
|
0.39%
1/255
|
|
General disorders
Mucosal inflammation
|
0.00%
0/234
|
0.78%
2/255
|
|
General disorders
Multi-organ failure
|
1.3%
3/234
|
1.2%
3/255
|
|
General disorders
Oedema
|
0.00%
0/234
|
0.39%
1/255
|
|
General disorders
Pain
|
0.00%
0/234
|
0.39%
1/255
|
|
General disorders
Performance status decreased
|
0.00%
0/234
|
0.39%
1/255
|
|
General disorders
Drug intolerance
|
0.00%
0/234
|
0.39%
1/255
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/234
|
0.39%
1/255
|
|
Hepatobiliary disorders
Biliary colic
|
0.43%
1/234
|
0.00%
0/255
|
|
Hepatobiliary disorders
Cholecystitis
|
0.43%
1/234
|
0.00%
0/255
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.85%
2/234
|
0.00%
0/255
|
|
Hepatobiliary disorders
Chronic hepatitis
|
0.43%
1/234
|
0.00%
0/255
|
|
Hepatobiliary disorders
Cytolytic hepatitis
|
0.43%
1/234
|
0.39%
1/255
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.85%
2/234
|
0.00%
0/255
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.43%
1/234
|
0.00%
0/255
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.43%
1/234
|
0.00%
0/255
|
|
Hepatobiliary disorders
Hepatotoxicity
|
1.7%
4/234
|
0.39%
1/255
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.85%
2/234
|
0.39%
1/255
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
0.85%
2/234
|
0.39%
1/255
|
|
Immune system disorders
Acute graft versus host disease
|
0.85%
2/234
|
2.7%
7/255
|
|
Immune system disorders
Acute graft versus host disease in intestine
|
2.1%
5/234
|
2.4%
6/255
|
|
Immune system disorders
Acute graft versus host disease in liver
|
2.1%
5/234
|
0.39%
1/255
|
|
Immune system disorders
Acute graft versus host disease in skin
|
0.43%
1/234
|
0.00%
0/255
|
|
Immune system disorders
Bone marrow transplant rejection
|
0.43%
1/234
|
0.00%
0/255
|
|
Immune system disorders
Chronic graft versus host disease
|
0.43%
1/234
|
1.2%
3/255
|
|
Immune system disorders
Graft versus host disease
|
3.8%
9/234
|
3.1%
8/255
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/234
|
0.39%
1/255
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/234
|
0.39%
1/255
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/234
|
0.39%
1/255
|
|
Infections and infestations
Clostridium difficile colitis
|
0.43%
1/234
|
0.00%
0/255
|
|
Infections and infestations
Escherichia sepsis
|
0.43%
1/234
|
0.39%
1/255
|
|
Infections and infestations
Klebsiella infection
|
0.43%
1/234
|
0.00%
0/255
|
|
Infections and infestations
Klebsiella sepsis
|
0.43%
1/234
|
0.00%
0/255
|
|
Infections and infestations
Lung infection pseudomonal
|
0.43%
1/234
|
0.00%
0/255
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/234
|
0.78%
2/255
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/234
|
0.39%
1/255
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/234
|
0.39%
1/255
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.43%
1/234
|
0.00%
0/255
|
|
Infections and infestations
Staphylococcal infection
|
0.43%
1/234
|
0.78%
2/255
|
|
Infections and infestations
Stenotrophomonas infection
|
0.43%
1/234
|
0.00%
0/255
|
|
Infections and infestations
Aspergillosis
|
0.00%
0/234
|
0.39%
1/255
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/234
|
0.78%
2/255
|
|
Infections and infestations
Fungal infection
|
0.43%
1/234
|
0.39%
1/255
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.43%
1/234
|
0.00%
0/255
|
|
Infections and infestations
Bacteraemia
|
0.43%
1/234
|
0.00%
0/255
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/234
|
0.78%
2/255
|
|
Infections and infestations
Central line infection
|
1.3%
3/234
|
0.00%
0/255
|
|
Infections and infestations
Ear infection
|
0.00%
0/234
|
0.78%
2/255
|
|
Infections and infestations
Gastroenteritis
|
0.43%
1/234
|
0.00%
0/255
|
|
Infections and infestations
Lung infection
|
0.43%
1/234
|
0.39%
1/255
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/234
|
1.2%
3/255
|
|
Infections and infestations
Pneumonia
|
1.7%
4/234
|
1.6%
4/255
|
|
Infections and infestations
Respiratory tract infection
|
0.43%
1/234
|
0.00%
0/255
|
|
Infections and infestations
Sepsis
|
1.3%
3/234
|
1.6%
4/255
|
|
Infections and infestations
Septic shock
|
0.43%
1/234
|
1.6%
4/255
|
|
Infections and infestations
Sinusitis
|
0.00%
0/234
|
0.39%
1/255
|
|
Infections and infestations
Urinary tract infection
|
0.43%
1/234
|
0.00%
0/255
|
|
Infections and infestations
BK virus infection
|
0.00%
0/234
|
0.39%
1/255
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/234
|
0.39%
1/255
|
|
Infections and infestations
Cytomegalovirus gastrointestinal infection
|
0.43%
1/234
|
0.00%
0/255
|
|
Infections and infestations
Cytomegalovirus infection
|
3.8%
9/234
|
4.3%
11/255
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.43%
1/234
|
0.39%
1/255
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/234
|
0.39%
1/255
|
|
Infections and infestations
Human herpesvirus 6 infection
|
0.43%
1/234
|
0.39%
1/255
|
|
Infections and infestations
Meningoencephalitis herpetic
|
0.43%
1/234
|
0.00%
0/255
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/234
|
0.39%
1/255
|
|
Infections and infestations
Oral herpes
|
0.00%
0/234
|
0.39%
1/255
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/234
|
0.78%
2/255
|
|
Infections and infestations
Viral infection
|
0.00%
0/234
|
0.39%
1/255
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/234
|
0.39%
1/255
|
|
Injury, poisoning and procedural complications
Lung injury
|
0.00%
0/234
|
0.39%
1/255
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.85%
2/234
|
0.39%
1/255
|
|
Investigations
Electrocardiogram QT prolonged
|
0.43%
1/234
|
0.00%
0/255
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/234
|
0.39%
1/255
|
|
Investigations
Haematocrit decreased
|
0.00%
0/234
|
0.39%
1/255
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/234
|
0.39%
1/255
|
|
Investigations
Alanine aminotransferase increased
|
0.85%
2/234
|
1.2%
3/255
|
|
Investigations
Aspartate aminotransferase increased
|
0.43%
1/234
|
0.78%
2/255
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/234
|
0.39%
1/255
|
|
Investigations
Hepatic enzyme increased
|
0.43%
1/234
|
0.00%
0/255
|
|
Investigations
Liver function test abnormal
|
1.7%
4/234
|
0.00%
0/255
|
|
Investigations
Cytomegalovirus antigen positive
|
0.00%
0/234
|
0.39%
1/255
|
|
Investigations
Cytomegalovirus test
|
0.85%
2/234
|
0.78%
2/255
|
|
Investigations
Cytomegalovirus test positive
|
0.85%
2/234
|
0.39%
1/255
|
|
Investigations
Gram stain positive
|
0.00%
0/234
|
0.39%
1/255
|
|
Investigations
Respiratory syncytial virus test positive
|
0.43%
1/234
|
0.00%
0/255
|
|
Investigations
Weight
|
0.00%
0/234
|
0.39%
1/255
|
|
Investigations
Weight decreased
|
0.85%
2/234
|
0.39%
1/255
|
|
Investigations
Blood creatinine increased
|
0.43%
1/234
|
0.00%
0/255
|
|
Investigations
Serum ferritin increased
|
0.43%
1/234
|
0.39%
1/255
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/234
|
0.39%
1/255
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/234
|
0.78%
2/255
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/234
|
0.39%
1/255
|
|
Metabolism and nutrition disorders
Dehydration
|
0.43%
1/234
|
0.00%
0/255
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/234
|
0.39%
1/255
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.43%
1/234
|
0.00%
0/255
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.43%
1/234
|
0.39%
1/255
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/234
|
0.39%
1/255
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/234
|
0.39%
1/255
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.43%
1/234
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.43%
1/234
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.43%
1/234
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.43%
1/234
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.43%
1/234
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.43%
1/234
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
0.85%
2/234
|
1.6%
4/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.43%
1/234
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
0.43%
1/234
|
1.2%
3/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/234
|
0.39%
1/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disseminated large cell lymphoma
|
0.00%
0/234
|
0.39%
1/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.43%
1/234
|
0.39%
1/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.85%
2/234
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.43%
1/234
|
0.00%
0/255
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.43%
1/234
|
0.00%
0/255
|
|
Nervous system disorders
Meningorrhagia
|
0.43%
1/234
|
0.00%
0/255
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/234
|
0.39%
1/255
|
|
Nervous system disorders
Leukoencephalopathy
|
0.43%
1/234
|
0.00%
0/255
|
|
Nervous system disorders
Headache
|
0.43%
1/234
|
0.00%
0/255
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/234
|
0.39%
1/255
|
|
Nervous system disorders
Monoplegia
|
0.43%
1/234
|
0.00%
0/255
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/234
|
0.39%
1/255
|
|
Nervous system disorders
Dizziness
|
0.43%
1/234
|
0.00%
0/255
|
|
Nervous system disorders
Lethargy
|
0.43%
1/234
|
0.00%
0/255
|
|
Nervous system disorders
Loss of consciousness
|
0.43%
1/234
|
0.39%
1/255
|
|
Nervous system disorders
Nervous system disorder
|
0.43%
1/234
|
0.00%
0/255
|
|
Nervous system disorders
Presyncope
|
0.00%
0/234
|
0.78%
2/255
|
|
Nervous system disorders
Neuropathy peripheral
|
0.43%
1/234
|
0.00%
0/255
|
|
Nervous system disorders
Convulsion
|
0.85%
2/234
|
0.00%
0/255
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/234
|
0.78%
2/255
|
|
Psychiatric disorders
Depression
|
0.00%
0/234
|
0.39%
1/255
|
|
Psychiatric disorders
Hallucination, visual
|
0.85%
2/234
|
0.00%
0/255
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
1.3%
3/234
|
2.4%
6/255
|
|
Renal and urinary disorders
Renal failure
|
0.85%
2/234
|
0.78%
2/255
|
|
Renal and urinary disorders
Renal failure acute
|
1.3%
3/234
|
0.39%
1/255
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/234
|
0.78%
2/255
|
|
Renal and urinary disorders
Dysuria
|
0.43%
1/234
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/234
|
0.39%
1/255
|
|
Respiratory, thoracic and mediastinal disorders
Obliterative bronchiolitis
|
0.43%
1/234
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.85%
2/234
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/234
|
0.39%
1/255
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.43%
1/234
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/234
|
0.78%
2/255
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/234
|
0.39%
1/255
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.43%
1/234
|
0.39%
1/255
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.43%
1/234
|
0.39%
1/255
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.85%
2/234
|
0.39%
1/255
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/234
|
1.2%
3/255
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.43%
1/234
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/234
|
0.39%
1/255
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.85%
2/234
|
2.0%
5/255
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/234
|
0.39%
1/255
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.43%
1/234
|
0.00%
0/255
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.43%
1/234
|
0.78%
2/255
|
|
Surgical and medical procedures
Subdural haematoma evacuation
|
0.43%
1/234
|
0.00%
0/255
|
|
Vascular disorders
Extremity necrosis
|
0.43%
1/234
|
0.00%
0/255
|
|
Vascular disorders
Hypotension
|
0.43%
1/234
|
0.39%
1/255
|
|
Vascular disorders
Jugular vein thrombosis
|
0.43%
1/234
|
0.00%
0/255
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.43%
1/234
|
0.00%
0/255
|
|
Vascular disorders
Thrombosis
|
0.00%
0/234
|
0.39%
1/255
|
|
Vascular disorders
Vena cava thrombosis
|
0.43%
1/234
|
0.00%
0/255
|
|
Vascular disorders
Venous thrombosis
|
0.43%
1/234
|
0.00%
0/255
|
Other adverse events
| Measure |
Voriconazole
n=234 participants at risk
Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects \< 40 kg body weight).
|
Itraconazole
n=255 participants at risk
Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.8%
30/234
|
11.8%
30/255
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.0%
35/234
|
16.1%
41/255
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
21.8%
51/234
|
26.7%
68/255
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.0%
21/234
|
11.8%
30/255
|
|
Cardiac disorders
Tachycardia
|
5.6%
13/234
|
2.4%
6/255
|
|
Eye disorders
Visual impairment
|
6.4%
15/234
|
0.78%
2/255
|
|
Gastrointestinal disorders
Constipation
|
17.5%
41/234
|
8.2%
21/255
|
|
Gastrointestinal disorders
Diarrhoea
|
42.7%
100/234
|
51.8%
132/255
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.1%
12/234
|
2.0%
5/255
|
|
Gastrointestinal disorders
Abdominal pain
|
19.2%
45/234
|
19.6%
50/255
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.8%
23/234
|
8.2%
21/255
|
|
Gastrointestinal disorders
Dyspepsia
|
10.7%
25/234
|
8.6%
22/255
|
|
Gastrointestinal disorders
Nausea
|
36.8%
86/234
|
35.7%
91/255
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
78/234
|
40.4%
103/255
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.1%
12/234
|
3.9%
10/255
|
|
Gastrointestinal disorders
Oral pain
|
6.4%
15/234
|
4.7%
12/255
|
|
Gastrointestinal disorders
Stomatitis
|
7.3%
17/234
|
6.7%
17/255
|
|
General disorders
Catheter related complication
|
4.7%
11/234
|
5.1%
13/255
|
|
General disorders
Catheter site erythema
|
6.8%
16/234
|
3.9%
10/255
|
|
General disorders
Pyrexia
|
44.9%
105/234
|
39.6%
101/255
|
|
General disorders
Asthenia
|
8.1%
19/234
|
12.2%
31/255
|
|
General disorders
Chest pain
|
5.6%
13/234
|
4.3%
11/255
|
|
General disorders
Chills
|
7.3%
17/234
|
9.0%
23/255
|
|
General disorders
Fatigue
|
15.0%
35/234
|
7.5%
19/255
|
|
General disorders
Mucosal inflammation
|
49.1%
115/234
|
55.7%
142/255
|
|
General disorders
Oedema
|
5.6%
13/234
|
5.1%
13/255
|
|
General disorders
Oedema peripheral
|
15.8%
37/234
|
16.5%
42/255
|
|
Hepatobiliary disorders
Cholestasis
|
6.0%
14/234
|
3.9%
10/255
|
|
Hepatobiliary disorders
Cytolytic hepatitis
|
6.4%
15/234
|
3.1%
8/255
|
|
Hepatobiliary disorders
Hepatotoxicity
|
8.1%
19/234
|
3.1%
8/255
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.1%
5/234
|
5.1%
13/255
|
|
Immune system disorders
Acute graft versus host disease
|
5.1%
12/234
|
6.3%
16/255
|
|
Immune system disorders
Graft versus host disease
|
15.4%
36/234
|
14.1%
36/255
|
|
Infections and infestations
Folliculitis
|
5.1%
12/234
|
4.3%
11/255
|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
12/234
|
3.1%
8/255
|
|
Infections and infestations
Cytomegalovirus infection
|
9.4%
22/234
|
6.7%
17/255
|
|
Investigations
Haemoglobin decreased
|
5.6%
13/234
|
3.1%
8/255
|
|
Investigations
Alanine aminotransferase increased
|
5.1%
12/234
|
1.6%
4/255
|
|
Investigations
Liver function test abnormal
|
7.3%
17/234
|
3.5%
9/255
|
|
Investigations
Weight increased
|
4.3%
10/234
|
5.1%
13/255
|
|
Metabolism and nutrition disorders
Anorexia
|
8.1%
19/234
|
9.8%
25/255
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.8%
9/234
|
7.1%
18/255
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.0%
21/234
|
11.8%
30/255
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.7%
4/234
|
6.7%
17/255
|
|
Metabolism and nutrition disorders
Fluid retention
|
6.0%
14/234
|
7.1%
18/255
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.1%
12/234
|
11.8%
30/255
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.1%
12/234
|
4.7%
12/255
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.1%
12/234
|
3.1%
8/255
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
18/234
|
8.6%
22/255
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.1%
33/234
|
10.6%
27/255
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.0%
21/234
|
9.4%
24/255
|
|
Nervous system disorders
Headache
|
26.9%
63/234
|
27.1%
69/255
|
|
Nervous system disorders
Tremor
|
4.7%
11/234
|
7.5%
19/255
|
|
Nervous system disorders
Dizziness
|
5.6%
13/234
|
3.5%
9/255
|
|
Nervous system disorders
Paraesthesia
|
6.0%
14/234
|
2.0%
5/255
|
|
Psychiatric disorders
Anxiety
|
6.4%
15/234
|
7.1%
18/255
|
|
Psychiatric disorders
Insomnia
|
9.8%
23/234
|
6.7%
17/255
|
|
Renal and urinary disorders
Renal failure
|
8.1%
19/234
|
4.7%
12/255
|
|
Renal and urinary disorders
Dysuria
|
5.6%
13/234
|
5.9%
15/255
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.2%
45/234
|
16.5%
42/255
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.3%
17/234
|
5.1%
13/255
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.0%
21/234
|
8.6%
22/255
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.8%
16/234
|
6.3%
16/255
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.5%
20/234
|
11.8%
30/255
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.8%
16/234
|
4.7%
12/255
|
|
Skin and subcutaneous tissue disorders
Erythema
|
18.4%
43/234
|
15.3%
39/255
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.7%
25/234
|
9.4%
24/255
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.5%
48/234
|
17.6%
45/255
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
3.0%
7/234
|
5.1%
13/255
|
|
Vascular disorders
Hypotension
|
6.8%
16/234
|
7.1%
18/255
|
|
Vascular disorders
Hypertension
|
18.8%
44/234
|
19.2%
49/255
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 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