Trial Outcomes & Findings for Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant (NCT NCT04933968)
NCT ID: NCT04933968
Last Updated: 2024-06-06
Results Overview
A TEAE was defined as an adverse event (AE) with a start date and time on or after the first dose of study treatment. A serious AE (SAE) was an AE that met at least one of the following serious criteria: fatal, life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other important medical event. TEAEs of special interest (AESI) included new/worsening graft versus host disease, graft failure or rejection, cytokine release syndrome, infusion related reactions, new/worsening pneumonitis, and progressive dyspnea. Treatment-related refers to the assessment of a relationship between study treatment and the event by the investigator.
TERMINATED
PHASE1/PHASE2
17 participants
Day 1 up to 12 months
2024-06-06
Participant Flow
Participants were enrolled at study centers in the United States and participated from March 2022 until January 2024.
Participants with respiratory tract infections and clinical manifestations caused by respiratory syncytial virus, influenza virus, human metapneumovirus, and/or parainfluenza virus following hematopoietic cell or solid organ transplants were enrolled. Participants were randomized in a double-blind manner to receive placebo or one of four dose levels of ALVR106, from Dose A (lower dose) to Dose D (higher dose). Due to early study termination, no participants were enrolled into Part B.
Participant milestones
| Measure |
Part A: Placebo
Participants were randomized to receive placebo, and were administered placebo as an intravenous (IV) infusion on Day 1. Participants returned to the clinic for assessments up to Day 14, and based on assessments could receive a second infusion of placebo on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 1: Dose A
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose A as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose A on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 2: Dose B
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose B as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose B on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 3: Dose C
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose C as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose C on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 4: Dose D
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose D as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose D on Day 14. Participants were followed for up to 12 months.
|
Part B Expansion Cohort
It was planned to enroll and randomize participants at high-risk with upper respiratory tract infections into Part B to receive placebo or ALVR106 at the recommended Phase 2 dose (RP2D). Due to the early termination of the study, no participants were enrolled into the Part B expansion cohort.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
4
|
4
|
3
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
4
|
4
|
3
|
0
|
Reasons for withdrawal
| Measure |
Part A: Placebo
Participants were randomized to receive placebo, and were administered placebo as an intravenous (IV) infusion on Day 1. Participants returned to the clinic for assessments up to Day 14, and based on assessments could receive a second infusion of placebo on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 1: Dose A
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose A as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose A on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 2: Dose B
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose B as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose B on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 3: Dose C
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose C as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose C on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 4: Dose D
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose D as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose D on Day 14. Participants were followed for up to 12 months.
|
Part B Expansion Cohort
It was planned to enroll and randomize participants at high-risk with upper respiratory tract infections into Part B to receive placebo or ALVR106 at the recommended Phase 2 dose (RP2D). Due to the early termination of the study, no participants were enrolled into the Part B expansion cohort.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Randomized not treated
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Sponsor terminated study
|
0
|
0
|
0
|
1
|
2
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Missing
|
1
|
3
|
2
|
1
|
1
|
0
|
Baseline Characteristics
Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant
Baseline characteristics by cohort
| Measure |
Part A: Placebo
n=2 Participants
Participants were randomized to receive placebo, and were administered placebo as an IV infusion on Day 1. Participants returned to the clinic for assessments up to Day 14, and based on assessments could receive a second infusion of placebo on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 1: Dose A
n=3 Participants
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose A as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose A on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 2: Dose B
n=4 Participants
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose B as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose B on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 3: Dose C
n=4 Participants
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose C as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose C on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 4: Dose D
n=3 Participants
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose D as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose D on Day 14. Participants were followed for up to 12 months.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
≤ 18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Customized
19 - 70 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
|
Age, Customized
≥ 71 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 12 monthsPopulation: The safety population included all randomized participants who received any amount of ALVR106 or placebo.
A TEAE was defined as an adverse event (AE) with a start date and time on or after the first dose of study treatment. A serious AE (SAE) was an AE that met at least one of the following serious criteria: fatal, life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other important medical event. TEAEs of special interest (AESI) included new/worsening graft versus host disease, graft failure or rejection, cytokine release syndrome, infusion related reactions, new/worsening pneumonitis, and progressive dyspnea. Treatment-related refers to the assessment of a relationship between study treatment and the event by the investigator.
Outcome measures
| Measure |
Part A: Placebo
n=2 Participants
Participants were randomized to receive placebo, and were administered placebo as an IV infusion on Day 1. Participants returned to the clinic for assessments up to Day 14, and based on assessments could receive a second infusion of placebo on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 1: Dose A
n=3 Participants
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose A as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose A on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 2: Dose B
n=4 Participants
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose B as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose B on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 3: Dose C
n=4 Participants
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose C as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose C on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 4: Dose D
n=3 Participants
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose D as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose D on Day 14. Participants were followed for up to 12 months.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A)
Any AESI
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A)
Any treatment-related AESI
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A)
Any SAE
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A)
Any treatment-related SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A)
Any TEAE leading to study treatment discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A)
Any TEAE leading to death
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A)
Any TEAE
|
2 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A)
Any treatment-related TEAE
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 28 (Part B)Population: No participants were enrolled into Part B due to the early termination of the study.
Change from Baseline in viral load as measured by quantitative PCR of nasal swab
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 up to 12 monthsPopulation: All randomized participants who received ALVR106 in Part A.
The RP2D was to be determined after the maximum tolerated dose was reached in Part A.
Outcome measures
| Measure |
Part A: Placebo
n=14 Participants
Participants were randomized to receive placebo, and were administered placebo as an IV infusion on Day 1. Participants returned to the clinic for assessments up to Day 14, and based on assessments could receive a second infusion of placebo on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 1: Dose A
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose A as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose A on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 2: Dose B
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose B as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose B on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 3: Dose C
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose C as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose C on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 4: Dose D
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose D as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose D on Day 14. Participants were followed for up to 12 months.
|
|---|---|---|---|---|---|
|
Identify the Recommended Phase 2 Dose (RP2D) (Part A)
|
NA x 10^5 cells/kg
The MTD and RP2D could not be determined due to too few dose-limiting toxicities during the study prior to early study termination.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 28Population: The modified intent-to-treat population included all randomized participants who received any amount of ALVR106 or placebo and had confirmed virologic infection of interest at baseline (detectable viral load). Participants with baseline and Day 28 available data are included.
Viral load was measured by quantitative polymerase chain reaction (PCR) of nasal swab specimens. The cycle threshold value categorizes the concentration of viral genetic material in a participant's swab specimen, and the cycle threshold value represents the number of PCR cycles required to amplify the viral genetic material (as measured by fluorescence) to a detectable level that is distinguishable from baseline fluorescence, providing an estimate of viral load. Lower cycle threshold values indicate higher viral load and high values indicate lower viral load. A positive change from baseline indicates a decrease in the viral load. The baseline measurement was from a pre-dose nasal swab.
Outcome measures
| Measure |
Part A: Placebo
n=1 Participants
Participants were randomized to receive placebo, and were administered placebo as an IV infusion on Day 1. Participants returned to the clinic for assessments up to Day 14, and based on assessments could receive a second infusion of placebo on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 1: Dose A
n=1 Participants
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose A as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose A on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 2: Dose B
n=4 Participants
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose B as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose B on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 3: Dose C
n=4 Participants
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose C as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose C on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 4: Dose D
n=3 Participants
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose D as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose D on Day 14. Participants were followed for up to 12 months.
|
|---|---|---|---|---|---|
|
Change in Viral Load Cycle Threshold From Baseline to Day 28 (Part A)
|
8.60 cycles
Standard Deviation NA
Standard deviation could not be determined as 1 participant was analyzed.
|
4.40 cycles
Standard Deviation NA
Standard deviation could not be determined as 1 participant was analyzed.
|
8.43 cycles
Standard Deviation 6.118
|
5.78 cycles
Standard Deviation 4.696
|
7.47 cycles
Standard Deviation 7.551
|
SECONDARY outcome
Timeframe: Day 1 up to 12 monthsPopulation: No participants were enrolled into Part B due to the early termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 and Month 6Population: No participants were enrolled into Part B due to the early termination of the study.
Outcome measures
Outcome data not reported
Adverse Events
Part A: Placebo
Part A ALVR106 Cohort 1: Dose A
Part A ALVR106 Cohort 2: Dose B
Part A ALVR106 Cohort 3: Dose C
Part A ALVR106 Cohort 4: Dose D
Serious adverse events
| Measure |
Part A: Placebo
n=2 participants at risk
Participants were randomized to receive placebo, and were administered placebo as an IV infusion on Day 1. Participants returned to the clinic for assessments up to Day 14, and based on assessments could receive a second infusion of placebo on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 1: Dose A
n=3 participants at risk
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose A as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose A on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 2: Dose B
n=4 participants at risk
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose B as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose B on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 3: Dose C
n=4 participants at risk
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose C as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose C on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 4: Dose D
n=3 participants at risk
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose D as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose D on Day 14. Participants were followed for up to 12 months.
|
|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
50.0%
2/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Investigations
Liver function test increased
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Viral haemorrhagic cystitis
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Septic shock
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
Other adverse events
| Measure |
Part A: Placebo
n=2 participants at risk
Participants were randomized to receive placebo, and were administered placebo as an IV infusion on Day 1. Participants returned to the clinic for assessments up to Day 14, and based on assessments could receive a second infusion of placebo on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 1: Dose A
n=3 participants at risk
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose A as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose A on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 2: Dose B
n=4 participants at risk
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose B as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose B on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 3: Dose C
n=4 participants at risk
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose C as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose C on Day 14. Participants were followed for up to 12 months.
|
Part A ALVR106 Cohort 4: Dose D
n=3 participants at risk
Participants were randomized to receive ALVR106, and were administered ALVR106 Dose D as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose D on Day 14. Participants were followed for up to 12 months.
|
|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
50.0%
1/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
75.0%
3/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
66.7%
2/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
BK virus infection
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Otitis media
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Gastrointestinal disorders
Hyperaesthesia teeth
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
General disorders
Pyrexia
|
50.0%
1/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
General disorders
Fatigue
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
General disorders
Non-cardiac chest pain
|
50.0%
1/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
General disorders
Chills
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
General disorders
Influenza like illness
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
50.0%
2/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
50.0%
2/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Investigations
Blood lactate dehydrogenase increased
|
50.0%
1/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Investigations
Transfer factor reduced
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Investigations
Vitamin D decreased
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
50.0%
2/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
50.0%
1/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Immune system disorders
Acute graft versus host disease in skin
|
50.0%
1/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Immune system disorders
Chronic graft versus host disease in lung
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Immune system disorders
Chronic graft versus host disease oral
|
50.0%
1/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Nervous system disorders
Muscle tension dysphonia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Vascular disorders
Hot flush
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Endocrine disorders
Hypogonadism
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Congenital, familial and genetic disorders
Chimerism
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Eye disorders
Dry eye
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
25.0%
1/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/2 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
0.00%
0/4 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
33.3%
1/3 • Day 1 up to 12 months.
AEs are presented for the safety population for Part A which included all randomized participants who received any amount of ALVR106 or placebo. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the AE data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place