Trial Outcomes & Findings for A Study Evaluating the Safety and Pharmacokinetics of Atezolizumab Administered in Combination With Hu5F9-G4 to Patients With Relapsed and/or Refractory Acute Myeloid Leukemia (NCT NCT03922477)
NCT ID: NCT03922477
Last Updated: 2022-02-21
Results Overview
Percentage of participants with at least one adverse event.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
Up to approximately 13 months after first participant enrolled
Results posted on
2022-02-21
Participant Flow
Participant milestones
| Measure |
Atezolizumab + Hu5F9-G4
An initial safety evaluation was performed in participants with relapsed AML. If atezolizumab in combination with Hu5F9-G4 was initially safe and tolerable in participants an additional cohort with R/R AML was to be evaluated to further test the safety and anti-tumor activity. Atezolizumab was administered to participants by IV infusion at a fixed dose of 840 mg starting on Day 22 of Cycle 1. In subsequent cycles, IV atezolizumab was given every 2 weeks (Q2W) on Days 8 and 22 of each 28-day cycle. Two priming doses of 1 mg/kg of Hu5F9-G4 were administered to participants by continuous IV infusion on Days 1 and 4 of Cycle 1, followed by loading doses of 15 mg/kg IV on Day 8 and 30 mg/kg IV on Day 11. Starting on Day 15 of Cycle 1, Hu5F9-G4 maintenance was given by IV infusion at a dose of 30 mg/kg once a week (QW) of each 28-day cycle.
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|---|---|
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Overall Study
STARTED
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13
|
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Atezolizumab + Hu5F9-G4
An initial safety evaluation was performed in participants with relapsed AML. If atezolizumab in combination with Hu5F9-G4 was initially safe and tolerable in participants an additional cohort with R/R AML was to be evaluated to further test the safety and anti-tumor activity. Atezolizumab was administered to participants by IV infusion at a fixed dose of 840 mg starting on Day 22 of Cycle 1. In subsequent cycles, IV atezolizumab was given every 2 weeks (Q2W) on Days 8 and 22 of each 28-day cycle. Two priming doses of 1 mg/kg of Hu5F9-G4 were administered to participants by continuous IV infusion on Days 1 and 4 of Cycle 1, followed by loading doses of 15 mg/kg IV on Day 8 and 30 mg/kg IV on Day 11. Starting on Day 15 of Cycle 1, Hu5F9-G4 maintenance was given by IV infusion at a dose of 30 mg/kg once a week (QW) of each 28-day cycle.
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|---|---|
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Overall Study
Death
|
9
|
|
Overall Study
Fall leading to death prior to treatment initiation.
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
A Study Evaluating the Safety and Pharmacokinetics of Atezolizumab Administered in Combination With Hu5F9-G4 to Patients With Relapsed and/or Refractory Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Atezolizumab + Hu5F9-G4
n=13 Participants
An initial safety evaluation was performed in participants with relapsed AML. If atezolizumab in combination with Hu5F9-G4 was initially safe and tolerable in participants an additional cohort with R/R AML was to be evaluated to further test the safety and anti-tumor activity. Atezolizumab was administered to participants by IV infusion at a fixed dose of 840 mg starting on Day 22 of Cycle 1. In subsequent cycles, IV atezolizumab was given every 2 weeks (Q2W) on Days 8 and 22 of each 28-day cycle. Two priming doses of 1 mg/kg of Hu5F9-G4 were administered to participants by continuous IV infusion on Days 1 and 4 of Cycle 1, followed by loading doses of 15 mg/kg IV on Day 8 and 30 mg/kg IV on Day 11. Starting on Day 15 of Cycle 1, Hu5F9-G4 maintenance was given by IV infusion at a dose of 30 mg/kg once a week (QW) of each 28-day cycle.
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|---|---|
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Age, Continuous
|
68.9 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 13 months after first participant enrolledPopulation: Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
Percentage of participants with at least one adverse event.
Outcome measures
| Measure |
Atezolizumab + Hu5F9-G4
n=11 Participants
An initial safety evaluation was performed in participants with relapsed AML. If atezolizumab in combination with Hu5F9-G4 was initially safe and tolerable in participants an additional cohort with R/R AML was to be evaluated to further test the safety and anti-tumor activity. Atezolizumab was administered to participants by IV infusion at a fixed dose of 840 mg starting on Day 22 of Cycle 1. In subsequent cycles, IV atezolizumab was given every 2 weeks (Q2W) on Days 8 and 22 of each 28-day cycle. Two priming doses of 1 mg/kg of Hu5F9-G4 were administered to participants by continuous IV infusion on Days 1 and 4 of Cycle 1, followed by loading doses of 15 mg/kg IV on Day 8 and 30 mg/kg IV on Day 11. Starting on Day 15 of Cycle 1, Hu5F9-G4 maintenance was given by IV infusion at a dose of 30 mg/kg once a week (QW) of each 28-day cycle.
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|---|---|
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Percentage of Participants With Adverse Events
|
100 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to approximately 3 months after first participant enrolledPopulation: The efficacy analysis population included all participants who received any amount of either study drug, with participants grouped as a whole.
The CR rate is assessed as the percentage of participants who achieve a CR, complete remission with incomplete platelet recovery (CRp), complete remission with incomplete hematologic recovery (CRi), or complete remission with partial hematologic recovery (CRh) (as defined by the IWG 2003 and ELN 2010 criteria) after up to six cycles of combination therapy.
Outcome measures
| Measure |
Atezolizumab + Hu5F9-G4
n=11 Participants
An initial safety evaluation was performed in participants with relapsed AML. If atezolizumab in combination with Hu5F9-G4 was initially safe and tolerable in participants an additional cohort with R/R AML was to be evaluated to further test the safety and anti-tumor activity. Atezolizumab was administered to participants by IV infusion at a fixed dose of 840 mg starting on Day 22 of Cycle 1. In subsequent cycles, IV atezolizumab was given every 2 weeks (Q2W) on Days 8 and 22 of each 28-day cycle. Two priming doses of 1 mg/kg of Hu5F9-G4 were administered to participants by continuous IV infusion on Days 1 and 4 of Cycle 1, followed by loading doses of 15 mg/kg IV on Day 8 and 30 mg/kg IV on Day 11. Starting on Day 15 of Cycle 1, Hu5F9-G4 maintenance was given by IV infusion at a dose of 30 mg/kg once a week (QW) of each 28-day cycle.
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|---|---|
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Complete Remission (CR)
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to approximately 3 months after first particpant enrolledPopulation: The efficacy analysis population included all participants who received any amount of either study drug, with participants grouped as a whole. No participants were analyzed because no participants responded.
DOR is defined as the time from the initial response (CR, CRp, CRi, CRh, or partial remission \[PR\]) to the time of disease progression or death, whichever occurs first
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: C1 D22 PTFI of Hu5F9-G4 and atezolizumab, and 30 minutes after atezolizumab infusion; C2 D8 PTFI; C2 D22 PTFI; C3 D22 PTFI; C4 D22 PTFI; C8 D22 PTFI; C12 D22 PTFI; C16 D22 PTFI; TDV (up to C16 D21);120 days after final dose of atezolizumab (UTA 37M)Population: Samples for PK analysis were collected, but due to the small number of participants which reduces the scientific merit of any analysis no PK assays were performed and samples were discarded, hence no PK data are available.
C=cycle (cycle=28 days) ; D=day; PTFI=prior to first infusion; TDV=treatment discontinuation visit; UTA=up to approximately; M=month
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: C1D1 PTFI&1H AEOI; C1D8 PTFI,&1H AEOI; C1D11 PTFI,&1H AEOI; C1D22 1H AEOI; C2D1 PTFI,&1H AEOI; C2D8 PTFI; C3D1 PTFI,&1H AEOI; C5D1 PTFI; C7D1 PTFI, C9D1 PTFI; C11D1 PTFI; C13D1 PTFI; C15D1 PTFI; C17D1&D1 E 2C T PTFI(UTA 37M);TDV(up to C16D21)(UTA 37M)Population: Samples for PK analysis were collected, but due to the small number of participants which reduces the scientific merit of any analysis no PK assays were performed and samples were discarded, hence no PK data are available.
C=cycle (cycle=28 days); D=Day; PTFI=prior to first infusion; H=hour; AEOI=after end of infusion; TDV=treatment discontinuation visit; UTA=up to approximately; M=months; E=every; T=thereafter
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 3 months after first participant enrolledPopulation: The efficacy analysis population included all participants who received any amount of either study drug, with participants grouped as a whole.
Objective response rate is defined as the percentage of participants with a partial remission (PR) or better (i.e., CR + CRp + CRi + CRh+ PR).
Outcome measures
| Measure |
Atezolizumab + Hu5F9-G4
n=11 Participants
An initial safety evaluation was performed in participants with relapsed AML. If atezolizumab in combination with Hu5F9-G4 was initially safe and tolerable in participants an additional cohort with R/R AML was to be evaluated to further test the safety and anti-tumor activity. Atezolizumab was administered to participants by IV infusion at a fixed dose of 840 mg starting on Day 22 of Cycle 1. In subsequent cycles, IV atezolizumab was given every 2 weeks (Q2W) on Days 8 and 22 of each 28-day cycle. Two priming doses of 1 mg/kg of Hu5F9-G4 were administered to participants by continuous IV infusion on Days 1 and 4 of Cycle 1, followed by loading doses of 15 mg/kg IV on Day 8 and 30 mg/kg IV on Day 11. Starting on Day 15 of Cycle 1, Hu5F9-G4 maintenance was given by IV infusion at a dose of 30 mg/kg once a week (QW) of each 28-day cycle.
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|---|---|
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Objective Response Rate
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 3 months after first participant enrolledPopulation: The efficacy analysis population included all participants who received any amount of either study drug, with participants grouped as a whole.
Event-free survival is defined as the time from study entry to the date of induction treatment failure or relapse from CR, CRp, CRh, CRi, or death from any cause.
Outcome measures
| Measure |
Atezolizumab + Hu5F9-G4
n=11 Participants
An initial safety evaluation was performed in participants with relapsed AML. If atezolizumab in combination with Hu5F9-G4 was initially safe and tolerable in participants an additional cohort with R/R AML was to be evaluated to further test the safety and anti-tumor activity. Atezolizumab was administered to participants by IV infusion at a fixed dose of 840 mg starting on Day 22 of Cycle 1. In subsequent cycles, IV atezolizumab was given every 2 weeks (Q2W) on Days 8 and 22 of each 28-day cycle. Two priming doses of 1 mg/kg of Hu5F9-G4 were administered to participants by continuous IV infusion on Days 1 and 4 of Cycle 1, followed by loading doses of 15 mg/kg IV on Day 8 and 30 mg/kg IV on Day 11. Starting on Day 15 of Cycle 1, Hu5F9-G4 maintenance was given by IV infusion at a dose of 30 mg/kg once a week (QW) of each 28-day cycle.
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|---|---|
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Event-Free Survival
|
1.7 Months
Interval 1.02 to 2.83
|
SECONDARY outcome
Timeframe: Up to approximately 3 months after first participant enrolledPopulation: No participants were analyzed because no participants received an objective response.
Leukemia-free survival is defined (only for participants achieving a CR, CRp, CRh, or CRi) as the time from the date of achievement of remission (CR, CRp, or CRi) until the date of relapse from CR, CRp, CRh, CRi, or death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 13 months after first participant enrolledPopulation: The efficacy analysis population included all participants who received any amount of either study drug, with participants grouped as a whole.
Overall survival is defined as time from study entry to the date of death from any cause.
Outcome measures
| Measure |
Atezolizumab + Hu5F9-G4
n=11 Participants
An initial safety evaluation was performed in participants with relapsed AML. If atezolizumab in combination with Hu5F9-G4 was initially safe and tolerable in participants an additional cohort with R/R AML was to be evaluated to further test the safety and anti-tumor activity. Atezolizumab was administered to participants by IV infusion at a fixed dose of 840 mg starting on Day 22 of Cycle 1. In subsequent cycles, IV atezolizumab was given every 2 weeks (Q2W) on Days 8 and 22 of each 28-day cycle. Two priming doses of 1 mg/kg of Hu5F9-G4 were administered to participants by continuous IV infusion on Days 1 and 4 of Cycle 1, followed by loading doses of 15 mg/kg IV on Day 8 and 30 mg/kg IV on Day 11. Starting on Day 15 of Cycle 1, Hu5F9-G4 maintenance was given by IV infusion at a dose of 30 mg/kg once a week (QW) of each 28-day cycle.
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|---|---|
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Overall Survival
|
4.1 Months
Interval 1.74 to 6.37
|
SECONDARY outcome
Timeframe: Up to approximately 3 months after first participant enrolledPopulation: The efficacy analysis population included all participants who received any amount of either study drug, with participants grouped as a whole.
Progression-free survival (Investigator) is defined as the time from the first day of study treatment to disease progression or death, whichever occurs first.
Outcome measures
| Measure |
Atezolizumab + Hu5F9-G4
n=11 Participants
An initial safety evaluation was performed in participants with relapsed AML. If atezolizumab in combination with Hu5F9-G4 was initially safe and tolerable in participants an additional cohort with R/R AML was to be evaluated to further test the safety and anti-tumor activity. Atezolizumab was administered to participants by IV infusion at a fixed dose of 840 mg starting on Day 22 of Cycle 1. In subsequent cycles, IV atezolizumab was given every 2 weeks (Q2W) on Days 8 and 22 of each 28-day cycle. Two priming doses of 1 mg/kg of Hu5F9-G4 were administered to participants by continuous IV infusion on Days 1 and 4 of Cycle 1, followed by loading doses of 15 mg/kg IV on Day 8 and 30 mg/kg IV on Day 11. Starting on Day 15 of Cycle 1, Hu5F9-G4 maintenance was given by IV infusion at a dose of 30 mg/kg once a week (QW) of each 28-day cycle.
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|---|---|
|
Progression-Free Survival
|
2.8 Months
Interval 1.48 to 3.02
|
SECONDARY outcome
Timeframe: Up to approximately 3 months after first participant enrolledPopulation: The efficacy analysis population included all participants who received any amount of either study drug, with participants grouped as a whole.
Rate of transfusion independence is defined as the percentage of participants who achieve transfusion independence (i.e., achieving any continuous 56-day window without requiring platelet or RBC transfusions) at any time during study treatment.
Outcome measures
| Measure |
Atezolizumab + Hu5F9-G4
n=11 Participants
An initial safety evaluation was performed in participants with relapsed AML. If atezolizumab in combination with Hu5F9-G4 was initially safe and tolerable in participants an additional cohort with R/R AML was to be evaluated to further test the safety and anti-tumor activity. Atezolizumab was administered to participants by IV infusion at a fixed dose of 840 mg starting on Day 22 of Cycle 1. In subsequent cycles, IV atezolizumab was given every 2 weeks (Q2W) on Days 8 and 22 of each 28-day cycle. Two priming doses of 1 mg/kg of Hu5F9-G4 were administered to participants by continuous IV infusion on Days 1 and 4 of Cycle 1, followed by loading doses of 15 mg/kg IV on Day 8 and 30 mg/kg IV on Day 11. Starting on Day 15 of Cycle 1, Hu5F9-G4 maintenance was given by IV infusion at a dose of 30 mg/kg once a week (QW) of each 28-day cycle.
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|---|---|
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Rate of Transfusion Independence
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 3 months after first participant enrolledPopulation: None of the participants achieved transfusion independence, hence duration of independence was not calculated.
Duration of transfusion independence is defined as the number of consecutive days of transfusion independence, measured from 1 day after the last transfusion to disease progression or subsequent transfusion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 37 monthsPopulation: Samples for ADA analysis were collected, but due to the small number of participants which reduces the scientific merit of any analysis no ADA assays were performed and samples were discarded, hence no ADA data are available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 37 monthsPopulation: Samples for ADA analysis were collected, but due to the small number of participants which reduces the scientific merit of any analysis no ADA assays were performed and samples were discarded, hence no ADA data are available.
Outcome measures
Outcome data not reported
Adverse Events
Safety_Cohort
Serious events: 10 serious events
Other events: 10 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Safety_Cohort
n=11 participants at risk
An initial safety evaluation was to be performed in participants with relapsed AML. A total of 19 participants were screened for enrollment; 8 failed screening. 13 were enrolled but only 11 received study treatment. All 11 patients enrolled in the safety cohort discontinued the study.
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|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.2%
2/11 • Number of events 3 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Infections and infestations
Pneumonia
|
45.5%
5/11 • Number of events 9 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Infections and infestations
Sepsis
|
9.1%
1/11 • Number of events 2 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Infections and infestations
Skin infection
|
9.1%
1/11 • Number of events 2 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Injury, poisoning and procedural complications
Fracture
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Nervous system disorders
Haemorrhage intracranial
|
9.1%
1/11 • Number of events 2 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Renal and urinary disorders
Haematuria
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
Other adverse events
| Measure |
Safety_Cohort
n=11 participants at risk
An initial safety evaluation was to be performed in participants with relapsed AML. A total of 19 participants were screened for enrollment; 8 failed screening. 13 were enrolled but only 11 received study treatment. All 11 patients enrolled in the safety cohort discontinued the study.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
9.1%
1/11 • Number of events 2 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
27.3%
3/11 • Number of events 3 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
36.4%
4/11 • Number of events 6 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
27.3%
3/11 • Number of events 3 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Blood and lymphatic system disorders
Anaemia
|
45.5%
5/11 • Number of events 11 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Blood and lymphatic system disorders
Haemolysis
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
18.2%
2/11 • Number of events 2 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Cardiac disorders
Cardiac failure
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Cardiac disorders
Pericardial effusion
|
18.2%
2/11 • Number of events 2 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Cardiac disorders
Sinus tachycardia
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Ear and labyrinth disorders
Hypoacusis
|
18.2%
2/11 • Number of events 2 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Gastrointestinal disorders
Anal incontinence
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Gastrointestinal disorders
Constipation
|
18.2%
2/11 • Number of events 3 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Gastrointestinal disorders
Diarrhoea
|
36.4%
4/11 • Number of events 6 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Gastrointestinal disorders
Dysphagia
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Gastrointestinal disorders
Gingival bleeding
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Gastrointestinal disorders
Nausea
|
36.4%
4/11 • Number of events 4 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Gastrointestinal disorders
Stomatitis
|
18.2%
2/11 • Number of events 3 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
2/11 • Number of events 2 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
General disorders
Chills
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
General disorders
Fatigue
|
36.4%
4/11 • Number of events 4 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
General disorders
Localised oedema
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
General disorders
Oedema peripheral
|
36.4%
4/11 • Number of events 5 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
General disorders
Pyrexia
|
27.3%
3/11 • Number of events 4 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Infections and infestations
Escherichia urinary tract infection
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Injury, poisoning and procedural complications
Contusion
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Injury, poisoning and procedural complications
Fall
|
18.2%
2/11 • Number of events 2 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Injury, poisoning and procedural complications
Febrile nonhaemolytic transfusion reaction
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
36.4%
4/11 • Number of events 4 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
9.1%
1/11 • Number of events 2 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Investigations
Blood alkaline phosphatase increased
|
18.2%
2/11 • Number of events 2 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Investigations
Blood creatinine increased
|
18.2%
2/11 • Number of events 4 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Investigations
Human rhinovirus test positive
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Investigations
Liver function test increased
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Investigations
Transaminases increased
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Investigations
Weight decreased
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Investigations
White blood cell count decreased
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
27.3%
3/11 • Number of events 3 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Nervous system disorders
Aphasia
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Nervous system disorders
Dysgeusia
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Number of events 3 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Nervous system disorders
Lethargy
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Psychiatric disorders
Agitation
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Psychiatric disorders
Anxiety
|
18.2%
2/11 • Number of events 2 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Psychiatric disorders
Confusional state
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Psychiatric disorders
Delirium
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Psychiatric disorders
Depression
|
18.2%
2/11 • Number of events 2 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Renal and urinary disorders
Acute kidney injury
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Renal and urinary disorders
Dysuria
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Renal and urinary disorders
Pollakiuria
|
18.2%
2/11 • Number of events 3 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
2/11 • Number of events 2 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.2%
2/11 • Number of events 3 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
18.2%
2/11 • Number of events 2 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
18.2%
2/11 • Number of events 2 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
27.3%
3/11 • Number of events 4 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
18.2%
2/11 • Number of events 2 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
27.3%
3/11 • Number of events 3 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.2%
2/11 • Number of events 2 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
1/11 • Number of events 1 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
27.3%
3/11 • Number of events 3 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Vascular disorders
Haematoma
|
9.1%
1/11 • Number of events 3 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Vascular disorders
Hypertension
|
18.2%
2/11 • Number of events 3 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
|
Vascular disorders
Hypotension
|
18.2%
2/11 • Number of events 2 • From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER