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A Pharmacokinetic Study of JK1211(Itraconazole [Itrizole]) Oral Solution in Participants With Deep Mycosis and Those With Febrile Neutropenia Suspected of Fungal Infection

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ClinicalTrials.gov Identifier: NCT00784368
Recruitment Status : Completed
First Posted : November 3, 2008
Results First Posted : July 25, 2013
Last Update Posted : July 25, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Mycoses
Candidiasis
Aspergillosis
Cryptococcosis
Blastomycosis
Histoplasmosis
Neutropenia
Interventions Drug: ITCZ Oral Solution
Drug: ITCZ-IV
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SFI (ITCZ Oral Solution Monotherapy) SFI (Switched Treatment) FN (Switched Treatment)
Hide Arm/Group Description Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous (into the vein) infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants with febrile (with fever) neutropenia (a decrease in white blood cells) (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Period Title: Overall Study
Started 16 16 23
Completed 8 5 12
Not Completed 8 11 11
Reason Not Completed
Physician Decision             0             0             6
Lack of Efficacy             2             0             1
Adverse Event             6             9             2
Diagnosis of fever             0             0             1
Worsening of complications             0             0             1
Worsening of symptoms             0             1             0
Withdrawal of informed consent             0             1             0
Arm/Group Title SFI (ITCZ Oral Solution Monotherapy) SFI (Switched Treatment) FN (Switched Treatment) Total
Hide Arm/Group Description Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Total of all reporting groups
Overall Number of Baseline Participants 15 16 22 53
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 16 participants 22 participants 53 participants
61.7  (13.6) 64.2  (12.0) 58.3  (12.7) 61.1  (12.8)
[1]
Measure Description: Data for Baseline characteristic (Age) was available for 53 participants who were included in Full Analysis Set (FAS) population. FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ oral solution (ITCZ-OS) and participants without efficacy data. One participant without any infection evidence was not included in FAS for SFI (ITCZ OS Monotherapy).
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 22 participants 53 participants
Female
1
   6.7%
6
  37.5%
7
  31.8%
14
  26.4%
Male
14
  93.3%
10
  62.5%
15
  68.2%
39
  73.6%
[1]
Measure Description: Data for Baseline characteristic (Gender) was available for 53 participants who were included in FAS population. FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. One participant without any infection evidence was not included in FAS for SFI (ITCZ OS Monotherapy).
1.Primary Outcome
Title Maximum Plasma Itraconazole Concentration (Cmax)
Hide Description The Cmax is defined as the maximum observed analyte concentration. Cmax was measured in microgram per milliliter (mcg/ml).
Time Frame Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all participants who received ITCZ-OS and had plasma concentration data. One participant without any infection evidence was also included in the PK population for SFI (ITCZ-OS). 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.
Arm/Group Title SFI (ITCZ Oral Solution Monotherapy) SFI (Switched Treatment) FN (Switched Treatment)
Hide Arm/Group Description:
Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 16 13 22
Mean (Standard Deviation)
Unit of Measure: mcg/ml
200 mg/day (n=11,5,12) 2.90  (1.48) 2.30  (1.12) 1.79  (0.682)
300 mg/day (n=4,2,0) 9.20  (2.39) 58.2 [1]   (NA) NA [2]   (NA)
400mg/day (n=1,6,10) 0.948 [3]   (NA) 6.10  (3.12) 2.44  (0.996)
[1]
Standard deviation obtained by sampling distribution of 2 participants was not meaningful, hence not reported.
[2]
No participant was administered 300 mg/day dose in the FN (Switched treatment) arm.
[3]
Standard deviation was not estimable since only 1 participant was evaluable.
2.Primary Outcome
Title Area Under the Curve From Time Zero to 24 Hours Post-dose Observed Plasma Itraconazole Concentration (AUC[0-24])
Hide Description The AUC(0-24) is area under the plasma concentration time curve from time zero (pre-dose) to 24 hours post-dose. It is usually calculated by linear trapezoidal method. AUC was measured in mcg*hour(hr) per ml.
Time Frame Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants who received ITCZ-OS and had plasma concentration data. One participant without any infection evidence was also included in the PK population, for SFI (ITCZ-OS). Here 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.
Arm/Group Title SFI (ITCZ Oral Solution Monotherapy) SFI (Switched Treatment) FN (Switched Treatment)
Hide Arm/Group Description:
Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 16 13 22
Mean (Standard Deviation)
Unit of Measure: mcg*hr per ml
200 mg/day (n=11,5,12) 55.8  (34.4) 41.0  (25.6) 31.4  (14.1)
300 mg/day (n=4,2,0) 207  (54.7) 129 [1]   (NA) NA [2]   (NA)
400mg/day (n=1,6,10) 19.0 [3]   (NA) 137  (71.3) 50.4  (23.5)
[1]
Standard deviation obtained by sampling distribution of 2 participants was not meaningful, hence not reported.
[2]
No participant was administered 300 mg/day dose in the FN (Switched treatment) arm.
[3]
Standard deviation was not estimable since only 1 participant was evaluable.
3.Primary Outcome
Title Minimum Inhibitory Concentration (MIC)
Hide Description The MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation.
Time Frame Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.
Arm/Group Title SFI (ITCZ Oral Solution Monotherapy) SFI (Switched Treatment)
Hide Arm/Group Description:
Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 4 5
Mean (Standard Deviation)
Unit of Measure: mcg per ml
200 mg/day (n=4,1) 0.438  (0.125) 0.06 [1]   (NA)
300 mg/day (n=0,1) NA [2]   (NA) 1.00 [1]   (NA)
400mg/day (n=0,3) NA [3]   (NA) 0.71  (0.51)
[1]
Standard deviation was not estimable since only 1 participant was evaluable.
[2]
No evaluable participant was treated with 300 mg/day, so it was not possible to evaluate the relationship between the dose level and the pharmacokinetic parameters.
[3]
No evaluable participant was treated with 400 mg/day, so it was not possible to evaluate the relationship between the dose level and the pharmacokinetic parameters.
4.Primary Outcome
Title Maximum Plasma Drug Concentration by Minimum Inhibitory Concentration (Cmax/MIC)
Hide Description The Cmax is maximum observed analyte concentration and MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The Cmax/MIC was calculated only in participants for whom the MIC was obtained.
Time Frame Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.
Arm/Group Title SFI (ITCZ Oral Solution Monotherapy) SFI (Switched Treatment)
Hide Arm/Group Description:
Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 4 5
Mean (Standard Deviation)
Unit of Measure: ratio
200 mg/day (n=4,1) 7.21  (2.13) 28.8 [1]   (NA)
300 mg/day (n=0,1) NA [2]   (NA) 5.81 [1]   (NA)
400 mg/day (n=0,3) NA [3]   (NA) 18.9  (21.6)
[1]
Standard deviation was not estimable since only 1 participant was evaluable.
[2]
No evaluable participant was treated with 300 mg/day, so it was not possible to evaluate the relationship between the dose level and the pharmacokinetic parameters.
[3]
No evaluable participant was treated with 400 mg/day, so it was not possible to evaluate the relationship between the dose level and the pharmacokinetic parameters.
5.Primary Outcome
Title Area Under the Curve During 24 Hours by Minimum Inhibitory Concentration (AUC 0-24/MIC)
Hide Description The AUC (0-24) is defined as area under the plasma concentration-time curve over the dosing interval (24 hr). It is usually calculated by linear trapezoidal method. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The AUC 0-24/MIC was calculated only in participants for whom the MIC was obtained.
Time Frame Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.
Arm/Group Title SFI (JK1211 Monotherapy) SFI (Switched Treatment)
Hide Arm/Group Description:
Participants with deep-seated mycosis (SFI) received JK1211 orally (taken by mouth; to be swallowed) in the dose range of 20 milliliter per day (ml/day) to 40 ml/day for 12 weeks as per Investigator’s discretion.
Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 4 5
Mean (Standard Deviation)
Unit of Measure: hour
200 mg/day (n=4,1) 147  (56.6) 399 [1]   (NA)
300 mg/day (n=0,1) NA [2]   (NA) 129 [1]   (NA)
400 mg/day (n=0,3) NA [3]   (NA) 421  (478)
[1]
Standard deviation was not estimable since only 1 participant was evaluable.
[2]
No evaluable participant was treated with 300 mg/day, so it was not possible to evaluate the relationship between the dose level and the pharmacokinetic parameters.
[3]
No evaluable participant was treated with 400 mg/day, so it was not possible to evaluate the relationship between the dose level and the pharmacokinetic parameters.
6.Primary Outcome
Title Time Above Minimum Inhibitory Concentration (T>MIC)
Hide Description The T>MIC was calculated only in participants for whom the MIC was obtained.
Time Frame Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.
Arm/Group Title SFI (ITCZ Oral Solution Monotherapy) SFI (Switched Treatment)
Hide Arm/Group Description:
Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 4 5
Mean (Standard Deviation)
Unit of Measure: percent time
200 mg/day (n=4,1) 100  (0) 100 [1]   (NA)
300 mg/day (n=0,1) NA [2]   (NA) 100 [1]   (NA)
400 mg/day (n=0,3) NA [3]   (NA) 100  (0)
[1]
Standard deviation was not estimable since only 1 participant was evaluable.
[2]
No evaluable participant was treated with 300 mg/day, so it was not possible to evaluate the relationship between the dose level and the pharmacokinetic parameters.
[3]
No evaluable participant was treated with 400 mg/day, so it was not possible to evaluate the relationship between the dose level and the pharmacokinetic parameters.
7.Secondary Outcome
Title Number of Participants With Change in Clinical Symptoms by Centralized Assessment
Hide Description Level of improvement in the clinical symptoms was assessed as: disappeared (if clinical symptoms disappeared), improved (significant improvement in clinical symptoms ), no change (almost no improvement in the clinical symptoms), worsened (if the clinical symptoms worsened) and could not be assessed (if it was difficult to make the above-noted assessments).
Time Frame Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.
Arm/Group Title SFI (ITCZ Oral Solution Monotherapy + Switched Treatment) FN (Switched Treatment)
Hide Arm/Group Description:
Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 31 22
Measure Type: Number
Unit of Measure: participants
Disappeared 7 6
Improved 12 12
No change 7 2
Worsened 2 0
Could not be assessed 3 2
8.Secondary Outcome
Title Number of Participants With Change in Clinical Symptoms by Diagnosis Name (Centralized Assessment)
Hide Description Level of improvement in the clinical symptoms was assessed as: disappeared (if clinical symptoms disappeared), improved (significant improvement in clinical symptoms ), no change (almost no improvement in the clinical symptoms), worsened (if the clinical symptoms worsened) and could not be assessed (if it was difficult to make the above-noted assessments). The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, chronic necrotic pulmonary aspergillosis (C.N.P.A), pulmonary aspergilloma (P.A.) and pulmonary cryptococcosis (P.C).
Time Frame Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.
Arm/Group Title SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)
Hide Arm/Group Description:
Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: participants
Candidemia: Improved (n=1) 1
Esophageal candidiasis: Disappeared (n=3) 3
Invasive aspergillosis: Disappeared (n=5) 2
Invasive aspergillosis: Improved (n=5) 1
Invasive aspergillosis: Worsened (n=5) 1
Invasive aspergillosis:Could not be assessed (n=5) 1
C.N.P.A: Improved (n= 8) 5
C.N.P.A: No change (n=8) 3
P.A.: Improved (n=10) 4
P.A.: No change (n=10) 4
P.A.: Could not be assessed (n=10) 2
P.C.: Disappeared (n=4) 2
P.C.: Improved (n=4) 1
P.C.: Worsened (n=4) 1
9.Secondary Outcome
Title Percentage of Participants With Overall Response by Centralized Assessment
Hide Description Efficacy rate (E.R.) was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective and cases for whom treatment was judged to be ineffective multiplied by 100. Treatment success rate (T.S.R.) was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective, cases for whom treatment was judged to be ineffective and cases for whom the efficacy could not be assessed multiplied by 100.
Time Frame Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.
Arm/Group Title SFI (ITCZ Oral Solution Monotherapy + Switched Treatment) FN (Switched Treatment)
Hide Arm/Group Description:
Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 31 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
E.R.
62.1
(42.3 to 79.3)
80.0
(56.3 to 94.3)
T.S.R
58.1
(39.1 to 75.5)
72.7
(49.8 to 89.3)
10.Secondary Outcome
Title Percentage of Participants With Overall Response by Diagnosis Name (Centralized Assessment)
Hide Description E.R. was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective and number of cases for whom treatment was judged to be ineffective multiplied by 100. T.S.R. was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective, number of cases for whom treatment was judged to be ineffective and number of cases for whom the efficacy could not be assessed multiplied by 100.
Time Frame Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.
Arm/Group Title SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)
Hide Arm/Group Description:
Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
E.R.: Candidemia (n=1)
100.0
(2.5 to 100)
E.R.: Esophageal candidiasis (n=3)
100.0
(29.2 to 100)
E.R.: Invasive aspergillosis (n=5)
60.0
(14.7 to 94.7)
E.R.: C.N.P.A (n=8)
62.5
(24.5 to 91.5)
E.R.: P.A. (n=10)
50.0
(15.7 to 84.3)
E.R.: P.C. (n=4)
50.0
(6.8 to 93.2)
T.S.R. : Candidemia (n=1)
100.0
(2.5 to 100)
T.S.R. : Esophageal candidiasis (n=3)
100.0
(29.2 to 100)
T.S.R. : Invasive aspergillosis (n=5)
60.0
(14.7 to 94.7)
T.S.R. : C.N.P.A (n=8)
62.5
(24.5 to 91.5)
T.S.R. : P.A. (n=10)
40.0
(12.2 to 73.8)
T.S.R. : P.C. (n=4)
50.0
(6.8 to 93.2)
11.Secondary Outcome
Title Number of Participants With Mycological Efficacy by Centralized Assessment
Hide Description Mycological efficacy was assessed as disappeared (if results for pathogenic fungus became negative, or if it was not possible to obtain the appropriate specimens), decreased (if level of pathogenic fungus was decreased in culture), no change (if there was no quantitative change in pathogenic fungus), increased (if there was a quantitative increase in pathogenic fungus, if results for pathogenic fungus became positive after start of dosing or if new pathogenic fungus was identified) , could not be assessed (if it was difficult to make the above assessment due to lack of detection in tests).
Time Frame Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.
Arm/Group Title SFI (ITCZ Oral Solution Monotherapy + Switched Treatment) FN (Switched Treatment)
Hide Arm/Group Description:
Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 31 22
Measure Type: Number
Unit of Measure: participants
Disappeared 6 0
No change 1 0
Could not be assessed 24 22
12.Secondary Outcome
Title Number of Participants With Mycological Efficacy by Diagnosis Name (Centralized Assessment)
Hide Description Mycological efficacy was assessed as disappeared, decreased, no change, increased, could not be assessed. The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, C.N.P.A, P.A. and P.C.
Time Frame Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.
Arm/Group Title SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)
Hide Arm/Group Description:
Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: participants
Candidemia: Could not be assessed (n=1) 1
Esophageal candidiasis: Disappeared (n=3) 1
Esophageal candidiasis:Could not be assessed (n=3) 2
Invasive aspergillosis:Could not be assessed (n=5) 5
C.N.P.A: Disappeared (n=8) 1
C.N.P.A: No change (n=8) 1
C.N.P.A: Could not be assessed (n=8) 6
P.A.: Disappeared (n=10) 3
P.A.: Could not be assessed (n=10) 7
P.C.: Disappeared (n=4) 1
P.C.: Could not be assessed (n=4) 3
13.Secondary Outcome
Title Number of Participants With Serological Effect Against Fungi by Centralized Assessment
Hide Description Serological effect against fungi was assessed as changed to negative (if the test values became negative), improved (if the test values decreased), no change (if there was no change in the test values), no change (if there was no change in the test values) , worsened (if the test values increased) and could not be assessed (if it was difficult to make the above-noted assessments due to a reason such as a lack of detection in the tests before and after dosing).
Time Frame Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.
Arm/Group Title SFI (ITCZ Oral Solution Monotherapy + Switched Treatment) FN (Switched Treatment)
Hide Arm/Group Description:
Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 31 22
Measure Type: Number
Unit of Measure: participants
Changed to negative 1 0
Improved 3 0
No change 5 1
Worsened 2 2
Could not be assessed 20 19
14.Secondary Outcome
Title Number of Participants With Serologic Effect Against Fungi by Diagnosis Name (Centralized Assessment)
Hide Description Serological effect against fungi was assessed as changed to negative (if the test values became negative), improved (if the test values decreased), no change (if there was no change in the test values), worsened (if the test values increased) and could not be assessed (if it was difficult to make above-noted assessments due to a reason such as a lack of detection in the tests before and after dosing). The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, C.N.P.A, P.A. and P.C.
Time Frame Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.
Arm/Group Title SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)
Hide Arm/Group Description:
Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: participants
Candidemia: Changed to negative (n=1) 1
Esophageal candidiasis:Could not be assessed (n=3) 3
Invasive aspergillosis: No change (n=5) 1
Invasive aspergillosis: Worsened (n=5) 1
Invasive aspergillosis:Could not be assessed (n=5) 3
C.N.P.A: Improved (n=8) 2
C.N.P.A: Worsened (n=8) 1
C.N.P.A: Could not be assessed (n=8) 5
P.A.:No change (n=10) 1
P.A.: Could not be assessed (n=10) 9
P.C.: Improved (n=4) 1
P.C.: No change (n=4) 3
15.Secondary Outcome
Title Number of Participants With Change In the Endoscopy or Image Diagnosis By Centralized Assessment
Hide Description Level of Improvement in the Endoscopy or Image diagnosis was assessed as disappeared (if the abnormal findings were normalized), decreased (if level of pathogenic fungus was decreased in culture), improved (if significant improvement was observed in the abnormal findings), no change (if no significant improvement was observed in the abnormal findings), worsened (if the abnormal findings were worsened) and could not be assessed (if it was difficult to make the above-noted assessments due to a reason such as a lack of detection in the tests before and after dosing).
Time Frame Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.
Arm/Group Title SFI (ITCZ Oral Solution Monotherapy + Switched Treatment) FN (Switched Treatment)
Hide Arm/Group Description:
Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 31 22
Measure Type: Number
Unit of Measure: participants
Disappeared 3 0
Improved 12 0
No change 7 0
Worsened 4 1
Could not be assessed 5 21
16.Secondary Outcome
Title Number of Participants With Change in the Endoscopy or Image Diagnosis by Diagnosis Name (Centralized Assessment)
Hide Description Level of Improvement in Endoscopy was assessed as disappeared, decreased, improved, no change, worsened and could not be assessed. The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, C.N.P.A, P.A. and P.C.
Time Frame Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.
Arm/Group Title SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)
Hide Arm/Group Description:
Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: participants
Candidemia: Could not be assessed (n=1) 1
Esophageal candidiasis: Disappeared (n=3) 3
Invasive aspergillosis: Improved (n=5) 3
Invasive aspergillosis: Worsened (n=5) 2
C.N.P.A: Improved (n=8) 3
C.N.P.A: No change (n=8) 3
C.N.P.A: Worsened (n=8) 2
P.A.:Improved (n=10) 3
P.A.:No change (n=10) 4
P.A.: Could not be assessed (n=10) 3
P.C.: Improved (n=4) 3
P.C.: Could not be assessed (n=4) 1
Time Frame Baseline up to 30 days after last dose of study drug
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SFI (ITCZ Oral Solution Monotherapy) SFI (Switched Treatment) FN (Switched Treatment)
Hide Arm/Group Description Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
All-Cause Mortality
SFI (ITCZ Oral Solution Monotherapy) SFI (Switched Treatment) FN (Switched Treatment)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SFI (ITCZ Oral Solution Monotherapy) SFI (Switched Treatment) FN (Switched Treatment)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/16 (25.00%)   8/16 (50.00%)   3/23 (13.04%) 
Blood and lymphatic system disorders       
Aplastic anemia * 1  0/16 (0.00%)  0/16 (0.00%)  1/23 (4.35%) 
Febrile neutropenia * 1  0/16 (0.00%)  0/16 (0.00%)  1/23 (4.35%) 
Cardiac disorders       
Pericarditis * 1  0/16 (0.00%)  1/16 (6.25%)  0/23 (0.00%) 
General disorders       
Edema * 1  0/16 (0.00%)  1/16 (6.25%)  0/23 (0.00%) 
Hepatobiliary disorders       
Cholestasis * 1  1/16 (6.25%)  0/16 (0.00%)  0/23 (0.00%) 
Infections and infestations       
Bronchitis * 1  1/16 (6.25%)  0/16 (0.00%)  0/23 (0.00%) 
Bronchopulmonary aspergillosis * 1  0/16 (0.00%)  1/16 (6.25%)  0/23 (0.00%) 
Pneumonia * 1  0/16 (0.00%)  1/16 (6.25%)  0/23 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  0/16 (0.00%)  1/16 (6.25%)  0/23 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Myelodysplastic syndrome * 1  0/16 (0.00%)  0/16 (0.00%)  1/23 (4.35%) 
Nervous system disorders       
Tremors * 1  0/16 (0.00%)  1/16 (6.25%)  0/23 (0.00%) 
Renal and urinary disorders       
Kidney damage * 1  1/16 (6.25%)  0/16 (0.00%)  0/23 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure * 1  0/16 (0.00%)  1/16 (6.25%)  0/23 (0.00%) 
Aspiration pneumonia * 1  0/16 (0.00%)  1/16 (6.25%)  0/23 (0.00%) 
Alveolar hemorrhage * 1  1/16 (6.25%)  0/16 (0.00%)  0/23 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SFI (ITCZ Oral Solution Monotherapy) SFI (Switched Treatment) FN (Switched Treatment)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/16 (93.75%)   16/16 (100.00%)   22/23 (95.65%) 
Blood and lymphatic system disorders       
Pancytopenia * 1  1/16 (6.25%)  0/16 (0.00%)  5/23 (21.74%) 
Febrile neutropenia * 1  1/16 (6.25%)  0/16 (0.00%)  3/23 (13.04%) 
Gastrointestinal disorders       
Diarrhoea * 1  8/16 (50.00%)  10/16 (62.50%)  6/23 (26.09%) 
Nausea * 1  1/16 (6.25%)  2/16 (12.50%)  3/23 (13.04%) 
Constipation * 1  2/16 (12.50%)  0/16 (0.00%)  2/23 (8.70%) 
Abdominal discomfort * 1  2/16 (12.50%)  1/16 (6.25%)  0/23 (0.00%) 
Vomiting * 1  1/16 (6.25%)  1/16 (6.25%)  1/23 (4.35%) 
Abdominal distension * 1  0/16 (0.00%)  1/16 (6.25%)  2/23 (8.70%) 
General disorders       
Oedema * 1  0/16 (0.00%)  3/16 (18.75%)  3/23 (13.04%) 
Oedema peripheral * 1  2/16 (12.50%)  2/16 (12.50%)  1/23 (4.35%) 
Hepatobiliary disorders       
Liver disorder * 1  5/16 (31.25%)  4/16 (25.00%)  10/23 (43.48%) 
Hepatic function abnormal * 1  1/16 (6.25%)  2/16 (12.50%)  0/23 (0.00%) 
Infections and infestations       
Nasopharyngitis * 1  0/16 (0.00%)  3/16 (18.75%)  1/23 (4.35%) 
Investigations       
Beta 2 microglobulin urine increased * 1  7/16 (43.75%)  7/16 (43.75%)  5/23 (21.74%) 
Beta-N-acetyl-D-glucosaminidase increased * 1  4/16 (25.00%)  2/16 (12.50%)  5/23 (21.74%) 
Alpha 1 microglobulin urine increased * 1  3/16 (18.75%)  3/16 (18.75%)  2/23 (8.70%) 
Blood cholesterol decreased * 1  1/16 (6.25%)  2/16 (12.50%)  4/23 (17.39%) 
C-reactive protein increased * 1  4/16 (25.00%)  1/16 (6.25%)  2/23 (8.70%) 
Blood triglycerides increased * 1  1/16 (6.25%)  0/16 (0.00%)  5/23 (21.74%) 
Platelet count decreased * 1  2/16 (12.50%)  2/16 (12.50%)  2/23 (8.70%) 
Urine analysis abnormal * 1  2/16 (12.50%)  1/16 (6.25%)  3/23 (13.04%) 
Blood bilirubin increased * 1  1/16 (6.25%)  0/16 (0.00%)  4/23 (17.39%) 
Blood creatine phosphokinase increased * 1  2/16 (12.50%)  3/16 (18.75%)  0/23 (0.00%) 
Blood glucose increased * 1  1/16 (6.25%)  1/16 (6.25%)  2/23 (8.70%) 
Metabolism and nutrition disorders       
Hypokalaemia * 1  3/16 (18.75%)  6/16 (37.50%)  12/23 (52.17%) 
Malnutrition * 1  0/16 (0.00%)  1/16 (6.25%)  8/23 (34.78%) 
Decreased appetite * 1  2/16 (12.50%)  1/16 (6.25%)  3/23 (13.04%) 
Hyperglycaemia * 1  0/16 (0.00%)  1/16 (6.25%)  2/23 (8.70%) 
Nervous system disorders       
Hypoaesthesia * 1  1/16 (6.25%)  1/16 (6.25%)  1/23 (4.35%) 
Renal and urinary disorders       
Renal disorder * 1  3/16 (18.75%)  2/16 (12.50%)  2/23 (8.70%) 
Renal tubular disorder * 1  2/16 (12.50%)  2/16 (12.50%)  2/23 (8.70%) 
Skin and subcutaneous tissue disorders       
Rash * 1  2/16 (12.50%)  2/16 (12.50%)  3/23 (13.04%) 
Vascular disorders       
Hypertension * 1  0/16 (0.00%)  1/16 (6.25%)  2/23 (8.70%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The disclosure restriction on PI is that the Sponsor can review results communications prior to public release and can embargo communications regarding results for a period as the sponsor requires.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Established Products
Organization: Global Medical Organization; Janssen R&D
Phone: (609) 730-7674
Layout table for additonal information
Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT00784368     History of Changes
Other Study ID Numbers: CR014299
JK1211-JPN-07 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Submitted: October 23, 2008
First Posted: November 3, 2008
Results First Submitted: March 21, 2013
Results First Posted: July 25, 2013
Last Update Posted: July 25, 2013