Trial Outcomes & Findings for Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis (NCT NCT00496197)
NCT ID: NCT00496197
Last Updated: 2011-10-03
Results Overview
Success: Clinical response=Cure (no signs, symptoms \[s/s\] of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (follow up \[f/u\] culture negative) or Presumed Eradication (f/u culture not available \[n/a\] and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida species \[spp\]) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
282 participants
Primary outcome timeframe
End of Treatment (Day 5 up to Day 42)
Results posted on
2011-10-03
Participant Flow
Participant milestones
| Measure |
Anidulafungin
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Overall Study
STARTED
|
282
|
|
Overall Study
COMPLETED
|
160
|
|
Overall Study
NOT COMPLETED
|
122
|
Reasons for withdrawal
| Measure |
Anidulafungin
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
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|---|---|
|
Overall Study
Discontinued study due to death
|
43
|
|
Overall Study
Adverse Event
|
13
|
|
Overall Study
Does not meet entrance criteria
|
5
|
|
Overall Study
Insufficient clinical response
|
3
|
|
Overall Study
Insufficient bacteriological response
|
10
|
|
Overall Study
Lost to Follow-up
|
11
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Pathogen not isolated baseline specimen
|
4
|
|
Overall Study
Other
|
14
|
|
Overall Study
Protocol Violation
|
8
|
Baseline Characteristics
Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis
Baseline characteristics by cohort
| Measure |
Anidulafungin
n=282 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Age, Customized
18 to 44 years of age
|
72 participants
n=5 Participants
|
|
Age, Customized
45 to 64 years of age
|
116 participants
n=5 Participants
|
|
Age, Customized
≥ 65 years of age
|
94 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
151 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of Treatment (Day 5 up to Day 42)Population: Modified Intent to Treat population (MITT): includes all participants who received at least 1 dose of study medication and with a positive baseline culture for a Candida spp. N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).
Success: Clinical response=Cure (no signs, symptoms \[s/s\] of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (follow up \[f/u\] culture negative) or Presumed Eradication (f/u culture not available \[n/a\] and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida species \[spp\]) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Outcome measures
| Measure |
Anidulafungin
n=203 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT)
Success (Cure or Improvement)
|
170 participants
|
|
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT)
Failure
|
33 participants
|
SECONDARY outcome
Timeframe: End of Treatment (Day 5 up to Day 42)Population: MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).
Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.
Outcome measures
| Measure |
Anidulafungin
n=187 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Number of Participants With Clinical Response at EOT
Cure
|
160 participants
|
|
Number of Participants With Clinical Response at EOT
Improvement
|
14 participants
|
|
Number of Participants With Clinical Response at EOT
Failure
|
13 participants
|
SECONDARY outcome
Timeframe: End of Treatment (Day 5 up to Day 42)Population: MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).
Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).
Outcome measures
| Measure |
Anidulafungin
n=192 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
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|---|---|
|
Number of Participants With Microbiological Response at EOT
Persistence
|
6 participants
|
|
Number of Participants With Microbiological Response at EOT
Presumed persistence
|
3 participants
|
|
Number of Participants With Microbiological Response at EOT
Eradication
|
124 participants
|
|
Number of Participants With Microbiological Response at EOT
Presumed eradication
|
59 participants
|
SECONDARY outcome
Timeframe: End of Intravenous treatment (Day 5 up to Day 28)Population: MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).
Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Outcome measures
| Measure |
Anidulafungin
n=235 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Intravenous Treatment (EOIV)
Success (Cure or Improvement)
|
208 participants
|
|
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Intravenous Treatment (EOIV)
Failure
|
27 participants
|
SECONDARY outcome
Timeframe: End of Intravenous treatment (Day 5 up to Day 28)Population: MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).
Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.
Outcome measures
| Measure |
Anidulafungin
n=232 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Number of Participants With Clinical Response at EOIV
Cure
|
159 participants
|
|
Number of Participants With Clinical Response at EOIV
Improvement
|
57 participants
|
|
Number of Participants With Clinical Response at EOIV
Failure
|
16 participants
|
SECONDARY outcome
Timeframe: End of Intravenous treatment (Day 5 up to Day 28)Population: MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).
Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).
Outcome measures
| Measure |
Anidulafungin
n=242 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Number of Participants With Microbiological Response at EOIV
Eradication
|
163 participants
|
|
Number of Participants With Microbiological Response at EOIV
Presumed eradication
|
61 participants
|
|
Number of Participants With Microbiological Response at EOIV
Persistence
|
15 participants
|
|
Number of Participants With Microbiological Response at EOIV
Presumed persistence
|
3 participants
|
SECONDARY outcome
Timeframe: Week 2 Follow-upPopulation: MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).
Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Outcome measures
| Measure |
Anidulafungin
n=194 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up
Failure
|
46 participants
|
|
Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up
Success (Cure or Improvement)
|
148 participants
|
SECONDARY outcome
Timeframe: Week 2 follow-upPopulation: MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).
Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.
Outcome measures
| Measure |
Anidulafungin
n=173 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up
Cure
|
155 participants
|
|
Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up
Improvement
|
9 participants
|
|
Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up
Failure
|
9 participants
|
SECONDARY outcome
Timeframe: Week 2 Follow-upPopulation: MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).
Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).
Outcome measures
| Measure |
Anidulafungin
n=173 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up
Eradication
|
30 participants
|
|
Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up
Presumed eradication
|
135 participants
|
|
Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up
Persistence
|
3 participants
|
|
Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up
Presumed persistence
|
5 participants
|
SECONDARY outcome
Timeframe: Week 6 Follow-up (EOS)Population: MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).
Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Outcome measures
| Measure |
Anidulafungin
n=187 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (End of Study [EOS])
Failure
|
56 participants
|
|
Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (End of Study [EOS])
Success (Cure or Improvement)
|
131 participants
|
SECONDARY outcome
Timeframe: Week 6 follow-up (EOS)Population: MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).
Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.
Outcome measures
| Measure |
Anidulafungin
n=156 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS)
Cure
|
138 participants
|
|
Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS)
Improvement
|
8 participants
|
|
Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS)
Failure
|
10 participants
|
SECONDARY outcome
Timeframe: Week 6 Follow-up (EOS)Population: MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).
Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).
Outcome measures
| Measure |
Anidulafungin
n=156 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS)
Eradication
|
12 participants
|
|
Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS)
Presumed eradication
|
134 participants
|
|
Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS)
Persistence
|
2 participants
|
|
Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS)
Presumed persistence
|
8 participants
|
SECONDARY outcome
Timeframe: End of Treatment (Day 5 up to Day 42)Population: MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).
Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Outcome measures
| Measure |
Anidulafungin
n=120 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOT for Participants With Non-albicans Candida at Baseline
Success (Cure or Improvement)
|
99 participants
|
|
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOT for Participants With Non-albicans Candida at Baseline
Failure
|
21 participants
|
SECONDARY outcome
Timeframe: End of Intravenous treatment (Day 5 up to Day 28)Population: MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).
Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Outcome measures
| Measure |
Anidulafungin
n=139 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOIV for Participants With Non-albicans Candida at Baseline
Success (Cure or Improvement)
|
119 participants
|
|
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOIV for Participants With Non-albicans Candida at Baseline
Failure
|
20 participants
|
SECONDARY outcome
Timeframe: Week 2 Follow-upPopulation: MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).
Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Outcome measures
| Measure |
Anidulafungin
n=116 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up for Participants With Non-albicans Candida at Baseline
Success (Cure or Improvement)
|
89 participants
|
|
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up for Participants With Non-albicans Candida at Baseline
Failure
|
27 participants
|
SECONDARY outcome
Timeframe: Week 6 Follow-up (EOS)Population: MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).
Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Outcome measures
| Measure |
Anidulafungin
n=111 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (EOS) for Participants With Non-albicans Candida at Baseline
Success (Cure or Improvement)
|
75 participants
|
|
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (EOS) for Participants With Non-albicans Candida at Baseline
Failure
|
36 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 6 Follow-up (EOS)Population: MITT; Confidence interval (CI) for the median could not be calculated by the software because no event time met the criteria for inclusion into the CI.
Participants with a negative culture on Day 1 were not included in the analysis. For participants with a positive culture on Day 1, the first day on which there was a negative culture was determined and then compared to the result of the next culture. If the next culture was also negative, or the next culture was positive but the interval between the 2 cultures was \> 3 days, the earlier of the 2 cultures was the day of first negative blood culture. If next culture was positive and taken within 3 days of the previous culture, the process was repeated with the next negative blood culture.
Outcome measures
| Measure |
Anidulafungin
n=282 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Time (75% Quartile Point Estimate) to Negative Blood and / or Tissue Culture for Candida Species
|
3.0000 days
Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: Baseline up to 6 Week Follow-up (EOS)Population: MITT; N=number of participants with analyzable data at observation. Time to dischargeable and time to discharge censored at Week 6 Follow-up (EOS).
Measured as time to dischargeable (medically dischargeable status) and as time to discharge (actual discharge). Analysis of length of hospital stay based on Kaplan-Meier survival techniques.
Outcome measures
| Measure |
Anidulafungin
n=248 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Medical Resource Utilization (MRU): Duration of Hospital Stay (Days)
Time to dischargeable
|
27.3 days
Standard Error 3.24
|
|
Medical Resource Utilization (MRU): Duration of Hospital Stay (Days)
Time to discharge
|
27.1 days
Standard Error 3.02
|
SECONDARY outcome
Timeframe: Baseline up to 6 Week Follow-up (EOS)Population: MITT; N=number of participants with analyzable data at observation. Length of hospital stay censored at Week 6 Follow-up (EOS).
Analysis of length of hospital stay based on Kaplan-Meier survival techniques.
Outcome measures
| Measure |
Anidulafungin
n=108 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Medical Resource Utilization (MRU): Duration of Intensive Care Unit or Critical Care Unit Stay (Days)
|
18.4 days
Standard Error 2.11
|
SECONDARY outcome
Timeframe: Baseline up to End of Intravenous treatment (Day 5 up to Day 28)Population: MITT; N=number of participants with analyzable data at observation. Length of hospital stay censored at Week 6 Follow-up (EOS).
Analysis of length of hospital stay based on Kaplan-Meier survival techniques.
Outcome measures
| Measure |
Anidulafungin
n=250 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Medical Resource Utilization (MRU): Duration of Intravenous Therapy (Days)
|
8.9 days
Standard Error 0.37
|
SECONDARY outcome
Timeframe: Baseline up to End of Treatment (Day 5 up to Day 42)Population: Intent to Treat (ITT) population includes all participants who received at least 1 dose of study medication.
Overall therapy includes Intravenous and Oral therapy. Participants were to receive at least 5 days and a maximum of 28 days of IV anidulafungin. After that, participants could continue treatment with oral fluconazole or voriconazole for at least 14 days from the day of last positive culture.
Outcome measures
| Measure |
Anidulafungin
n=282 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Medical Resource Utilization (MRU): Duration of Overall Therapy (Days)
|
14.1 days
Standard Deviation 8.21
|
SECONDARY outcome
Timeframe: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)Population: Safety analysis set is the same as the Intent-to-Treat population (ITT) and includes all participants who had taken at least 1 dose of study medication. N=number of participants who died with cause of death reported as Serious Adverse Events.
Cause of death (includes all-cause and attributable to Candida infection) reported based on death due to Serious Adverse Events (SAEs). SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect. Participants may be counted with \> 1 cause of death if multiple causes were present.
Outcome measures
| Measure |
Anidulafungin
n=65 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Number of Participants Per Specified Cause of Death
Lymphoma
|
3 participants
|
|
Number of Participants Per Specified Cause of Death
Mental status changes
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Multiple sclerosis relapse
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Myocardial infarction
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Neoplasm malignant
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Peritonitis
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Peritonitis bacterial
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Pneumothorax
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Pulmonary embolism
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Renal failure chronic
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Respiratory distress
|
2 participants
|
|
Number of Participants Per Specified Cause of Death
Respiratory failure
|
6 participants
|
|
Number of Participants Per Specified Cause of Death
Sepsis
|
12 participants
|
|
Number of Participants Per Specified Cause of Death
Septic shock
|
7 participants
|
|
Number of Participants Per Specified Cause of Death
Acute myocardial infarction
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Acute respiratory failure
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Bile duct cancer
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Haemorrhage
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Metastatic gastric cancer
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Multi-organ disorder
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Multi-organ failure
|
4 participants
|
|
Number of Participants Per Specified Cause of Death
Multiple myeloma
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Pneumonia
|
3 participants
|
|
Number of Participants Per Specified Cause of Death
Pulmonary haemorrhage
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Renal failure
|
5 participants
|
|
Number of Participants Per Specified Cause of Death
Renal failure acute
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Respiratory arrest
|
3 participants
|
|
Number of Participants Per Specified Cause of Death
Systemic candida
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Thrombocytopenia
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Wound dehiscence
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Anastomotic complication
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Ascites
|
2 participants
|
|
Number of Participants Per Specified Cause of Death
Atrial flutter
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Brain oedema
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Cardiac arrest
|
5 participants
|
|
Number of Participants Per Specified Cause of Death
Cardiac failure congestive
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Cardio-respiratory arrest
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Chronic hepatic failure
|
2 participants
|
|
Number of Participants Per Specified Cause of Death
Coagulopathy
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Colon cancer
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Convulsion
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Deep vein thrombosis
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Diabetes mellitus
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Disease progression
|
8 participants
|
|
Number of Participants Per Specified Cause of Death
Dyspnoea
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Electromechanical dissociation
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Endocarditis
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Endotracheal intubation
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Fungaemia
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Gastrointestinal haemorrhage
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Gastrointestinal ischaemia
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
General physical health deterioration
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Haemorrhage intracranial
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Hepatic failure
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Hypoglycaemia
|
2 participants
|
|
Number of Participants Per Specified Cause of Death
Hyponatraemia
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Hypotension
|
2 participants
|
|
Number of Participants Per Specified Cause of Death
Infection
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Ischaemic cardiomyopathy
|
1 participants
|
|
Number of Participants Per Specified Cause of Death
Liver function test abnormal
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)Population: Safety analysis set. An event may have been reported as both a serious and non-serious adverse event, however, what is presented are distinct events; participants may be counted as having experienced \> 1 event.
AEs are any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect.
Outcome measures
| Measure |
Anidulafungin
n=282 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Number of Participants With Non-serious and Serious Adverse Events
Non-serious Adverse Events
|
216 participants
|
|
Number of Participants With Non-serious and Serious Adverse Events
Serious Adverse Events
|
134 participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)Population: Safety analysis set
Outcome measures
| Measure |
Anidulafungin
n=282 Participants
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Number of Participants Who Died
|
65 participants
|
Adverse Events
Anidulafungin
Serious events: 134 serious events
Other events: 132 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anidulafungin
n=282 participants at risk
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Atrial flutter
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac arrest
|
2.1%
6/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac failure
|
0.71%
2/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.71%
2/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Electromechanical dissociation
|
0.71%
2/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Mitral valve disease
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.71%
2/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Tachycardia
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
5/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Ascites
|
1.1%
3/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
3/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal ischaemia
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
4/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Peritonitis
|
1.1%
3/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
3/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Device malfunction
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Disease progression
|
1.8%
5/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Local swelling
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Multi-organ disorder
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Multi-organ failure
|
1.4%
4/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Abdominal abscess
|
0.71%
2/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bacteraemia
|
1.4%
4/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bacterial sepsis
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Candidiasis
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Clostridium difficile colitis
|
1.4%
4/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Fungaemia
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Fungal endocarditis
|
0.71%
2/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Infection
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pancreatic abscess
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pelvic abscess
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Peridiverticular abscess
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Peritonitis bacterial
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
2.1%
6/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pyelonephritis
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sepsis
|
4.6%
13/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Septic shock
|
3.2%
9/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Systemic candida
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Wound infection bacterial
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Anastomotic haemorrhage
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Failure to anastomose
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Bleeding time prolonged
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood culture positive
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Hepatic enzyme increased
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Liver function test abnormal
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
5/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.71%
2/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.71%
2/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.71%
2/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
1.1%
3/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Brain oedema
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Convulsion
|
0.71%
2/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Intracranial hypotension
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Mental status changes
|
1.4%
4/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure
|
2.1%
6/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure acute
|
1.8%
5/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
3/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
3/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.71%
2/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.71%
2/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
1.4%
4/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.1%
3/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.5%
7/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Endotracheal intubation
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.71%
2/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Femoral artery embolism
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Haemorrhage
|
0.71%
2/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertensive crisis
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertensive emergency
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypotension
|
1.8%
5/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Phlebitis superficial
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Shock haemorrhagic
|
0.35%
1/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Anidulafungin
n=282 participants at risk
Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.7%
16/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
5.7%
16/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.3%
29/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
19/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
22/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
9.9%
28/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.0%
14/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.3%
15/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.3%
29/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.3%
15/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
6.0%
17/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
14/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypotension
|
6.0%
17/282 • Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER