Trial Outcomes & Findings for A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074) (NCT NCT01165320)
NCT ID: NCT01165320
Last Updated: 2018-08-27
Results Overview
Invasive candidiasis: favorable overall response required resolved clinical findings and negative culture test for Candida species on follow-up. If Candida species were not observed in the baseline blood culture, favorable overall response required resolved clinical findings and resolved or improved radiographic findings. Aspergillosis: favorable overall response required resolved, improved, or unchanged clinical findings and resolved or improved radiographic findings, or resolved or improved clinical findings and resolved, improved, or stable radiographic findings.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
Results posted on
2018-08-27
Participant Flow
Participants with documented esophageal candidiasis, invasive candidiasis, or aspergillosis and who met all of the additional inclusion and exclusion criteria were to be enrolled in the study
Three participants were initially enrolled but were withdrawn when their suspected fungal infections were not confirmed. These 3 participants did not receive study drug. No participants with esophageal candidiasis were identified for inclusion in the study.
Participant milestones
| Measure |
Participants With Invasive Candidiasis
MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
|
Participants With Aspergillosis
MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
|
Participants With Esophageal Candidiasis
MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 7 and 28 days, respectively.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
8
|
0
|
|
Overall Study
COMPLETED
|
9
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
0
|
Reasons for withdrawal
| Measure |
Participants With Invasive Candidiasis
MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
|
Participants With Aspergillosis
MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
|
Participants With Esophageal Candidiasis
MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 7 and 28 days, respectively.
|
|---|---|---|---|
|
Overall Study
Clinical adverse experience
|
2
|
1
|
0
|
|
Overall Study
Laboratory adverse experience
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
0
|
|
Overall Study
Reason unknown
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074)
Baseline characteristics by cohort
| Measure |
Participants With Invasive Candidiasis
n=12 Participants
MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
|
Participants With Aspergillosis
n=8 Participants
MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.8 Years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
9.8 Years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
9.8 Years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
Age, Customized
>=3 months and <2 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
>=2 years and <12 years
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Customized
>=12 years and <18 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Invasive candidiasis: up to 56 days; aspergillosis: up to 84 daysPopulation: The full analysis set included all enrolled participants who received \>=1 dose of study drug. No participants with esophageal candidiasis were identified for inclusion in the study and assessment for response to therapy. Participants whose overall response assessment was "unable to judge" were counted as having an unfavorable response.
Invasive candidiasis: favorable overall response required resolved clinical findings and negative culture test for Candida species on follow-up. If Candida species were not observed in the baseline blood culture, favorable overall response required resolved clinical findings and resolved or improved radiographic findings. Aspergillosis: favorable overall response required resolved, improved, or unchanged clinical findings and resolved or improved radiographic findings, or resolved or improved clinical findings and resolved, improved, or stable radiographic findings.
Outcome measures
| Measure |
Participants With Invasive Candidiasis
n=12 Participants
MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively
|
Participants With Aspergillosis
n=8 Participants
MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively
|
|---|---|---|
|
Percentage of Participants With an Overall Favorable Response to Therapy
|
66.7 Percentage of Participants
|
62.5 Percentage of Participants
|
PRIMARY outcome
Timeframe: Invasive candidiasis: up to 70 days; aspergillosis: up to 98 daysPopulation: The full analysis set included all enrolled participants who received \>=1 dose of study drug. No participants with esophageal candidiasis were identified for inclusion in the study and assessment for safety outcomes.
An adverse experience (AE) is defined as any unfavorable or unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. A drug-related AE is one judged to be definitely, probably, or possibly related to the study drug.
Outcome measures
| Measure |
Participants With Invasive Candidiasis
n=12 Participants
MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively
|
Participants With Aspergillosis
n=8 Participants
MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively
|
|---|---|---|
|
Percentage of Participants With One or More Drug-Related Adverse Experiences
|
58.3 Percentage of Participants
|
37.5 Percentage of Participants
|
Adverse Events
Participants With Invasive Candidiasis
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Participants With Aspergillosis
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants With Invasive Candidiasis
n=12 participants at risk
MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
|
Participants With Aspergillosis
n=8 participants at risk
MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
12.5%
1/8 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Infections and infestations
Sepsis
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
12.5%
1/8 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/12 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
12.5%
1/8 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
Other adverse events
| Measure |
Participants With Invasive Candidiasis
n=12 participants at risk
MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
|
Participants With Aspergillosis
n=8 participants at risk
MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Blood and lymphatic system disorders
Bone Marrow Failure
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Eye disorders
Ocular Icterus
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Gastrointestinal disorders
Abdominal Pain
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Gastrointestinal disorders
Haematochezia
|
16.7%
2/12 • Number of events 2 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.00%
0/12 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
12.5%
1/8 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
3/12 • Number of events 4 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
General disorders
Malaise
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
General disorders
Oedema
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
General disorders
Puncture Site Pain
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
General disorders
Pyrexia
|
25.0%
3/12 • Number of events 4 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
General disorders
Vessel Puncture Site Inflammation
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
16.7%
2/12 • Number of events 2 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
12.5%
1/8 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/12 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
12.5%
1/8 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Infections and infestations
Pseudomembranous Colitis
|
0.00%
0/12 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
12.5%
1/8 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Injury, poisoning and procedural complications
Excoriation
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Investigations
Alanine Aminotransferase Increased
|
33.3%
4/12 • Number of events 5 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
12.5%
1/8 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Investigations
Aspartate Aminotransferase Increased
|
25.0%
3/12 • Number of events 4 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
12.5%
1/8 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Investigations
Blood Bilirubin Increased
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
16.7%
2/12 • Number of events 2 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Investigations
Blood Urine Present
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Investigations
C-Reactive Protein Increased
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
25.0%
3/12 • Number of events 3 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Investigations
Heart Rate Increased
|
0.00%
0/12 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
12.5%
1/8 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Investigations
Platelet Count Increased
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Investigations
White Blood Cell Count Increased
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/12 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
12.5%
1/8 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
12.5%
1/8 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Number of events 3 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Renal and urinary disorders
Renal Impairment
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
0.00%
0/12 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
12.5%
1/8 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
4/12 • Number of events 7 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
12.5%
1/8 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Vascular disorders
Angiopathy
|
8.3%
1/12 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
0.00%
0/8 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
|
Vascular disorders
Venoocclusive Disease
|
0.00%
0/12 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
12.5%
1/8 • Number of events 1 • Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
No participants with esophageal candidiasis were identified for inclusion in the study and assessment for adverse events
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to publication or presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER