Trial Outcomes & Findings for Open-label Study of APX001 for Treatment of Patients With Invasive Mold Infections Caused by Aspergillus or Rare Molds (NCT NCT04240886)
NCT ID: NCT04240886
Last Updated: 2025-09-16
Results Overview
Percentage of participants who died after first dose in the study through Day 42 were reported in this outcome measure. This outcome measure included all deaths from Day 1 through Day 42.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
After first dose on Day 1 through Day 42
Results posted on
2025-09-16
Participant Flow
Study was planned to be conducted in two parallel cohorts: Cohort A included participants with invasive mold infections (IMA) and an exploratory Cohort B was planned to include participants with invasive aspergillus, who had COVID-19 or Influenza A/B. The study was terminated early and no participants were enrolled in Cohort B; hence data is not reported for Cohort B in any section.
Participant milestones
| Measure |
APX001 (Fosmanogepix): Cohort A
Eligible participants aged 18 years or older with invasive mold infections (IMI) and limited antifungal treatment options were included in this arm. On Day 1, participants received APX001 1000 milligram (mg) as a loading dose over 3 hours by intravenous (IV) infusion twice daily (BID). On Days 2 and 3, participants received APX001 600 mg as maintenance dose over 3 hours by IV infusion once daily (QD). From Day 4 till end of study treatment, for maintenance dose participants received either APX001 600 mg IV infusion QD over 3 hours or switched to APX001 800 mg orally QD on investigator discretion. Total treatment duration was maximum of 42 days. Participants had a follow-up visit at 4 weeks after last dose of study treatment and a follow-up telephone call was required on Day 84.
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|---|---|
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Treatment Phase
STARTED
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21
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|
Treatment Phase
COMPLETED
|
11
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Treatment Phase
NOT COMPLETED
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10
|
|
Follow-up Phase
STARTED
|
17
|
|
Follow-up Phase
COMPLETED
|
13
|
|
Follow-up Phase
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
APX001 (Fosmanogepix): Cohort A
Eligible participants aged 18 years or older with invasive mold infections (IMI) and limited antifungal treatment options were included in this arm. On Day 1, participants received APX001 1000 milligram (mg) as a loading dose over 3 hours by intravenous (IV) infusion twice daily (BID). On Days 2 and 3, participants received APX001 600 mg as maintenance dose over 3 hours by IV infusion once daily (QD). From Day 4 till end of study treatment, for maintenance dose participants received either APX001 600 mg IV infusion QD over 3 hours or switched to APX001 800 mg orally QD on investigator discretion. Total treatment duration was maximum of 42 days. Participants had a follow-up visit at 4 weeks after last dose of study treatment and a follow-up telephone call was required on Day 84.
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|---|---|
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Treatment Phase
Death
|
4
|
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Treatment Phase
Discontinuation by Subject
|
1
|
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Treatment Phase
Adverse Event
|
5
|
|
Follow-up Phase
Withdrawal by Subject
|
1
|
|
Follow-up Phase
Discontinuation by Subject
|
1
|
|
Follow-up Phase
Death
|
2
|
Baseline Characteristics
Open-label Study of APX001 for Treatment of Patients With Invasive Mold Infections Caused by Aspergillus or Rare Molds
Baseline characteristics by cohort
| Measure |
APX001 (Fosmanogepix): Cohort A
n=21 Participants
Eligible participants aged 18 years or older with invasive mold infections (IMI) and limited antifungal treatment options were included in this arm. On Day 1, participants received APX001 1000 milligram (mg) as a loading dose over 3 hours by intravenous (IV) infusion twice daily (BID). On Days 2 and 3, participants received APX001 600 mg as maintenance dose over 3 hours by IV infusion once daily (QD). From Day 4 till end of study treatment, for maintenance dose participants received either APX001 600 mg IV infusion QD over 3 hours or switched to APX001 800 mg orally QD on investigator discretion. Total treatment duration was maximum of 42 days. Participants had a follow-up visit at 4 weeks after last dose of study treatment and a follow-up telephone call was required on Day 84.
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|---|---|
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Age, Continuous
|
62.38 Years
STANDARD_DEVIATION 11.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: After first dose on Day 1 through Day 42Population: The modified Intent-to-Treat (mITT) population included all participants who entered in the study, received at least 1 dose of study drug, and had a diagnosis of proven or probable IMI confirmed by the DRC.
Percentage of participants who died after first dose in the study through Day 42 were reported in this outcome measure. This outcome measure included all deaths from Day 1 through Day 42.
Outcome measures
| Measure |
APX001 (Fosmanogepix): Cohort A
n=20 Participants
Eligible participants aged 18 years or older with invasive mold infections (IMI) and limited antifungal treatment options were included in this arm. On Day 1, participants received APX001 1000 milligram (mg) as a loading dose over 3 hours by intravenous (IV) infusion twice daily (BID). On Days 2 and 3, participants received APX001 600 mg as maintenance dose over 3 hours by IV infusion once daily (QD). From Day 4 till end of study treatment, for maintenance dose participants received either APX001 600 mg IV infusion QD over 3 hours or switched to APX001 800 mg orally QD on investigator discretion. Total treatment duration was maximum of 42 days. Participants had a follow-up visit at 4 weeks after last dose of study treatment and a follow-up telephone call was required on Day 84.
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|---|---|
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Percentage of Participants Who Died After the First Dose of Study Drug Through Day 42
|
25.0 Percentage of participants
Interval 12.7 to 41.5
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SECONDARY outcome
Timeframe: Any day from Day 1 until end of study treatment (any day up to Day 42)Population: mITT population included all participants who entered in the study, received at least 1 dose of study drug, and had a diagnosis of proven or probable IMI confirmed by the DRC.
Global response was classified as treatment success (complete or partial response \[CR or PR\]) or treatment failure (stable response \[SR\], progression of fungal disease \[PD\], or death) as determined by DRC. CR: survival within prespecified period of observation (PPOB), resolution of all attributable (att) symptoms and signs of disease and radiological (rad) abnormalities, and mycological (myco) evidence of eradication of disease. PR: survival within POB, improvement in att symptoms and signs of disease and rad abnormalities, and evidence of clearance of cultures or reduction of fungal burden. SR: survival within PPOB, minor or no improvement in fungal disease but no evidence of progression based on composite of clinical, rad and myco criteria, PD or death. PD: evidence of progressive fungal disease based on composite of clinical, rad and myco criteria. Death: death during PPOB, regardless of attribution. Data is presented for EOST which could have preceded Day 42 for some participants.
Outcome measures
| Measure |
APX001 (Fosmanogepix): Cohort A
n=20 Participants
Eligible participants aged 18 years or older with invasive mold infections (IMI) and limited antifungal treatment options were included in this arm. On Day 1, participants received APX001 1000 milligram (mg) as a loading dose over 3 hours by intravenous (IV) infusion twice daily (BID). On Days 2 and 3, participants received APX001 600 mg as maintenance dose over 3 hours by IV infusion once daily (QD). From Day 4 till end of study treatment, for maintenance dose participants received either APX001 600 mg IV infusion QD over 3 hours or switched to APX001 800 mg orally QD on investigator discretion. Total treatment duration was maximum of 42 days. Participants had a follow-up visit at 4 weeks after last dose of study treatment and a follow-up telephone call was required on Day 84.
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|---|---|
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Percentage of Participants With Global Response Based on Data Review Committee (DRC) Assessment at End of Study Drug Treatment (EOST)
CR
|
20.0 Percentage of participants
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Percentage of Participants With Global Response Based on Data Review Committee (DRC) Assessment at End of Study Drug Treatment (EOST)
PR
|
20.0 Percentage of participants
|
|
Percentage of Participants With Global Response Based on Data Review Committee (DRC) Assessment at End of Study Drug Treatment (EOST)
SR
|
10.0 Percentage of participants
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Percentage of Participants With Global Response Based on Data Review Committee (DRC) Assessment at End of Study Drug Treatment (EOST)
PD
|
30.0 Percentage of participants
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Percentage of Participants With Global Response Based on Data Review Committee (DRC) Assessment at End of Study Drug Treatment (EOST)
Death
|
20.0 Percentage of participants
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SECONDARY outcome
Timeframe: Any day from Day 1 until end of study treatment (any day up to Day 42)Population: mITT population included all participants who entered in the study, received at least 1 dose of study drug, and had a diagnosis of proven or probable IMI confirmed by the DRC.
Global response was classified as treatment success (CR or PR) or treatment failure (SR, PD or death) as determined by DRC. CR: survival within prespecified POB, resolution of all attributable symptoms and signs of disease and rad abnormalities and myco evidence of eradication of disease. PR: survival within prespecified POB, improvement in attributable symptoms and signs of disease and rad abnormalities and evidence of clearance of cultures or reduction of fungal burden. SR: survival within prespecified POB, minor or no improvement in fungal disease, but no evidence of progression, based on composite of clinical, rad, and myco criteria, PD or death. PD: evidence of PD based on a composite of clinical, rad, and myco criteria. Death: death during prespecified period of evaluation, regardless of attribution. Percentage of participants with treatment success (CR, PR) and treatment failure (SR, PD, death) along with two-sided exact binomial 80% confidence interval is presented.
Outcome measures
| Measure |
APX001 (Fosmanogepix): Cohort A
n=20 Participants
Eligible participants aged 18 years or older with invasive mold infections (IMI) and limited antifungal treatment options were included in this arm. On Day 1, participants received APX001 1000 milligram (mg) as a loading dose over 3 hours by intravenous (IV) infusion twice daily (BID). On Days 2 and 3, participants received APX001 600 mg as maintenance dose over 3 hours by IV infusion once daily (QD). From Day 4 till end of study treatment, for maintenance dose participants received either APX001 600 mg IV infusion QD over 3 hours or switched to APX001 800 mg orally QD on investigator discretion. Total treatment duration was maximum of 42 days. Participants had a follow-up visit at 4 weeks after last dose of study treatment and a follow-up telephone call was required on Day 84.
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|---|---|
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Percentage of Participants With Treatment Success or Treatment Failure for Global Response Based on Data Review Committee (DRC) Assessment at End of Study Drug Treatment (EOST)
Treatment Success
|
40.0 Percentage of participants
Interval 24.9 to 56.7
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|
Percentage of Participants With Treatment Success or Treatment Failure for Global Response Based on Data Review Committee (DRC) Assessment at End of Study Drug Treatment (EOST)
Treatment Failure
|
60.0 Percentage of participants
Interval 43.3 to 75.1
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SECONDARY outcome
Timeframe: Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days)Population: Safety population included all participants who received at least 1 dose of study drug.
An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to 4 weeks post last dose of study treatment that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. AEs included SAEs and all non-SAEs.
Outcome measures
| Measure |
APX001 (Fosmanogepix): Cohort A
n=21 Participants
Eligible participants aged 18 years or older with invasive mold infections (IMI) and limited antifungal treatment options were included in this arm. On Day 1, participants received APX001 1000 milligram (mg) as a loading dose over 3 hours by intravenous (IV) infusion twice daily (BID). On Days 2 and 3, participants received APX001 600 mg as maintenance dose over 3 hours by IV infusion once daily (QD). From Day 4 till end of study treatment, for maintenance dose participants received either APX001 600 mg IV infusion QD over 3 hours or switched to APX001 800 mg orally QD on investigator discretion. Total treatment duration was maximum of 42 days. Participants had a follow-up visit at 4 weeks after last dose of study treatment and a follow-up telephone call was required on Day 84.
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|---|---|
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
21 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
13 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days)Population: Safety population included all participants who received at least 1 dose of study drug.
Vital signs included body temperature, blood pressure, heart rate, respiratory rate, and oxygen saturation. Number of participants with clinically significant abnormality in vital signs as judged by investigator were reported in this outcome measure.
Outcome measures
| Measure |
APX001 (Fosmanogepix): Cohort A
n=21 Participants
Eligible participants aged 18 years or older with invasive mold infections (IMI) and limited antifungal treatment options were included in this arm. On Day 1, participants received APX001 1000 milligram (mg) as a loading dose over 3 hours by intravenous (IV) infusion twice daily (BID). On Days 2 and 3, participants received APX001 600 mg as maintenance dose over 3 hours by IV infusion once daily (QD). From Day 4 till end of study treatment, for maintenance dose participants received either APX001 600 mg IV infusion QD over 3 hours or switched to APX001 800 mg orally QD on investigator discretion. Total treatment duration was maximum of 42 days. Participants had a follow-up visit at 4 weeks after last dose of study treatment and a follow-up telephone call was required on Day 84.
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|---|---|
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Number of Participants With Clinically Significant Abnormality in Vital Signs
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5 Participants
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SECONDARY outcome
Timeframe: Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days)Population: Safety population included all participants who received at least 1 dose of study drug.
Clinical laboratory assessments included serum chemistry (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, creatinine, creatine kinase), hematology (including hemoglobin, hematocrit, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes), coagulation (including Prothrombin time \[PT\]/ International normalized ratio \[INR\]), and urinalysis. Number of participants with clinically significant abnormality in any laboratory parameter as judged by investigator and reported as adverse events were presented.
Outcome measures
| Measure |
APX001 (Fosmanogepix): Cohort A
n=21 Participants
Eligible participants aged 18 years or older with invasive mold infections (IMI) and limited antifungal treatment options were included in this arm. On Day 1, participants received APX001 1000 milligram (mg) as a loading dose over 3 hours by intravenous (IV) infusion twice daily (BID). On Days 2 and 3, participants received APX001 600 mg as maintenance dose over 3 hours by IV infusion once daily (QD). From Day 4 till end of study treatment, for maintenance dose participants received either APX001 600 mg IV infusion QD over 3 hours or switched to APX001 800 mg orally QD on investigator discretion. Total treatment duration was maximum of 42 days. Participants had a follow-up visit at 4 weeks after last dose of study treatment and a follow-up telephone call was required on Day 84.
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|---|---|
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Number of Participants With Clinically Significant Abnormality in Laboratory Test Evaluations
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12 Participants
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SECONDARY outcome
Timeframe: Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days)Population: Safety population included all participants who received at least 1 dose of study drug.
ECG parameters included PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and heart rate. Number of participants with clinically significant abnormal ECG findings as judged by investigator were presented.
Outcome measures
| Measure |
APX001 (Fosmanogepix): Cohort A
n=21 Participants
Eligible participants aged 18 years or older with invasive mold infections (IMI) and limited antifungal treatment options were included in this arm. On Day 1, participants received APX001 1000 milligram (mg) as a loading dose over 3 hours by intravenous (IV) infusion twice daily (BID). On Days 2 and 3, participants received APX001 600 mg as maintenance dose over 3 hours by IV infusion once daily (QD). From Day 4 till end of study treatment, for maintenance dose participants received either APX001 600 mg IV infusion QD over 3 hours or switched to APX001 800 mg orally QD on investigator discretion. Total treatment duration was maximum of 42 days. Participants had a follow-up visit at 4 weeks after last dose of study treatment and a follow-up telephone call was required on Day 84.
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|---|---|
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Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
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0 Participants
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SECONDARY outcome
Timeframe: Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days)Population: Safety population included all participants who received at least 1 dose of study drug.
Physical examination included an assessment of general appearance, skin, eyes, heart, chest, abdomen, and a neurological examination. Components of the neurological examination included cranial nerve, sensory, and motor examination; reflex and gait testing; and coordination assessment. Clinically significant changes were judged by investigator.
Outcome measures
| Measure |
APX001 (Fosmanogepix): Cohort A
n=21 Participants
Eligible participants aged 18 years or older with invasive mold infections (IMI) and limited antifungal treatment options were included in this arm. On Day 1, participants received APX001 1000 milligram (mg) as a loading dose over 3 hours by intravenous (IV) infusion twice daily (BID). On Days 2 and 3, participants received APX001 600 mg as maintenance dose over 3 hours by IV infusion once daily (QD). From Day 4 till end of study treatment, for maintenance dose participants received either APX001 600 mg IV infusion QD over 3 hours or switched to APX001 800 mg orally QD on investigator discretion. Total treatment duration was maximum of 42 days. Participants had a follow-up visit at 4 weeks after last dose of study treatment and a follow-up telephone call was required on Day 84.
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|---|---|
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Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examinations
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3 Participants
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SECONDARY outcome
Timeframe: Days 1, 2, 3, 4, 7: Pre-dose and 3 hours post-dose; Days 6, 13, 14: 3 hours post-dose, Day 15: pre-dosePopulation: The Pharmacokinetic (PK) Population included all participants who received any amount of study drug and had evaluable PK data. Here, "Number Analyzed" signifies participants evaluable at specified time points.
Outcome measures
| Measure |
APX001 (Fosmanogepix): Cohort A
n=21 Participants
Eligible participants aged 18 years or older with invasive mold infections (IMI) and limited antifungal treatment options were included in this arm. On Day 1, participants received APX001 1000 milligram (mg) as a loading dose over 3 hours by intravenous (IV) infusion twice daily (BID). On Days 2 and 3, participants received APX001 600 mg as maintenance dose over 3 hours by IV infusion once daily (QD). From Day 4 till end of study treatment, for maintenance dose participants received either APX001 600 mg IV infusion QD over 3 hours or switched to APX001 800 mg orally QD on investigator discretion. Total treatment duration was maximum of 42 days. Participants had a follow-up visit at 4 weeks after last dose of study treatment and a follow-up telephone call was required on Day 84.
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|---|---|
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Plasma Concentrations of Fosmanogepix
Day 1: Pre-dose
|
0.0 nanogram per milliliter
Geometric Coefficient of Variation 0.0
|
|
Plasma Concentrations of Fosmanogepix
Day 1: 3 hrs post-dose
|
387.4 nanogram per milliliter
Geometric Coefficient of Variation 289.6
|
|
Plasma Concentrations of Fosmanogepix
Day 2: Pre-dose
|
20.4 nanogram per milliliter
Geometric Coefficient of Variation 138.1
|
|
Plasma Concentrations of Fosmanogepix
Day 2: 3 hrs post-dose
|
406.4 nanogram per milliliter
Geometric Coefficient of Variation 202.9
|
|
Plasma Concentrations of Fosmanogepix
Day 3: Pre-dose
|
8.6 nanogram per milliliter
Geometric Coefficient of Variation 184.1
|
|
Plasma Concentrations of Fosmanogepix
Day 3: 3 hrs post-dose
|
486.7 nanogram per milliliter
Geometric Coefficient of Variation 154.6
|
|
Plasma Concentrations of Fosmanogepix
Day 4: Pre-dose
|
2.9 nanogram per milliliter
Geometric Coefficient of Variation 141.3
|
|
Plasma Concentrations of Fosmanogepix
Day 4: 3 hrs post-dose
|
85.2 nanogram per milliliter
Geometric Coefficient of Variation 14743.4
|
|
Plasma Concentrations of Fosmanogepix
Day 6: 3 hrs post-dose
|
6.8 nanogram per milliliter
Geometric Coefficient of Variation 1541.9
|
|
Plasma Concentrations of Fosmanogepix
Day 7: Pre-dose
|
9.8 nanogram per milliliter
Geometric Coefficient of Variation 716.5
|
|
Plasma Concentrations of Fosmanogepix
Day 7: 3 hrs post-dose
|
37.9 nanogram per milliliter
Geometric Coefficient of Variation 382.3
|
|
Plasma Concentrations of Fosmanogepix
Day 13: 3 hrs post-dose
|
96.4 nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as a single participant was analyzed
|
|
Plasma Concentrations of Fosmanogepix
Day 14: 3 hrs post-dose
|
706.8 nanogram per milliliter
Geometric Coefficient of Variation 181.0
|
|
Plasma Concentrations of Fosmanogepix
Day 15: Pre-dose
|
0.5 nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as a single participant was analyzed
|
Adverse Events
APX001 (Fosmanogepix): Cohort A
Serious events: 13 serious events
Other events: 21 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
APX001 (Fosmanogepix): Cohort A
n=21 participants at risk
Eligible participants aged 18 years or older with invasive mold infections (IMI) and limited antifungal treatment options were included in this arm. On Day 1, participants received APX001 1000 milligram (mg) as a loading dose over 3 hours by intravenous (IV) infusion twice daily (BID). On Days 2 and 3, participants received APX001 600 mg as maintenance dose over 3 hours by IV infusion once daily (QD). From Day 4 till end of study treatment, for maintenance dose participants received either APX001 600 mg IV infusion QD over 3 hours or switched to APX001 800 mg orally QD on investigator discretion. Total treatment duration was maximum of 42 days. Participants had a follow-up visit at 4 weeks after last dose of study treatment and a follow-up telephone call was required on Day 84.
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|---|---|
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Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
3/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Sudden death
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Catheter site infection
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Device related sepsis
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Endocarditis
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Fungal infection
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Stenotrophomonas bacteraemia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
APX001 (Fosmanogepix): Cohort A
n=21 participants at risk
Eligible participants aged 18 years or older with invasive mold infections (IMI) and limited antifungal treatment options were included in this arm. On Day 1, participants received APX001 1000 milligram (mg) as a loading dose over 3 hours by intravenous (IV) infusion twice daily (BID). On Days 2 and 3, participants received APX001 600 mg as maintenance dose over 3 hours by IV infusion once daily (QD). From Day 4 till end of study treatment, for maintenance dose participants received either APX001 600 mg IV infusion QD over 3 hours or switched to APX001 800 mg orally QD on investigator discretion. Total treatment duration was maximum of 42 days. Participants had a follow-up visit at 4 weeks after last dose of study treatment and a follow-up telephone call was required on Day 84.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
14.3%
3/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Pericarditis
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
14.3%
3/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Euthyroid sick syndrome
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
19.0%
4/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
3/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Anal incontinence
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
47.6%
10/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
61.9%
13/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Subileus
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
9/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
19.0%
4/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Facial pain
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
14.3%
3/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
General physical health deterioration
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Inflammation
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Malaise
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
28.6%
6/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
23.8%
5/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Jaundice
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Graft versus host disease
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Graft versus host disease in skin
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Atypical pneumonia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacterial disease carrier
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Colonic abscess
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Enterococcal bacteraemia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Escherichia bacteraemia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Moraxella infection
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral herpes
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pseudomonal sepsis
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Rhinovirus infection
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Febrile nonhaemolytic transfusion reaction
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin injury
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Vascular access site occlusion
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
3/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
19.0%
4/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
14.3%
3/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood calcium decreased
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine decreased
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood sodium decreased
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Drug level fluctuating
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Immunosuppressant drug level decreased
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
International normalised ratio increased
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet count decreased
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Spleen scan abnormal
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Weight increased
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.6%
6/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
14.3%
3/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Sarcopenia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia refractory
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral infarction
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
19.0%
4/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Presyncope
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Seizure
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Taste disorder
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Tremor
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Disorientation
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Restlessness
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Sleep disorder
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nocturia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Scrotal dermatitis
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
3/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.0%
4/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural thickening
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Haematoma
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
9.5%
2/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Subclavian vein thrombosis
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
19.0%
4/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
4.8%
1/21 • For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
|
Additional Information
Study Director
Basilea Pharmaceutica International Ltd, Allschwil
Phone: +41 79 701 0551
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor 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