Trial Outcomes & Findings for Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma (NCT NCT02858895)
NCT ID: NCT02858895
Last Updated: 2022-10-24
Results Overview
Primary endpoint analysis was based on the ITT population. The null hypothesis was mOS of 8.0 months, based on a clinically-weighted average of published studies of FDA-approved therapies versus the alternative hypothesis of 11.5 months.
COMPLETED
PHASE2
47 participants
From start of treatment until date of death from any cause. Subjects who were not known to have died at the time of the analysis were to be censored at the date of last contact.
2022-10-24
Participant Flow
Pre-treatment catheter trajectory planning performed to place up to 4 catheters, depending upon the tumor size.
Participant milestones
| Measure |
MDNA55
Subjects received a single infusion of MDNA55 (via convection enhanced delivery) at concentrations ranging from 1.5 to 9.0 μg/mL. Total dose administered did not exceed 240 μg (the established maximum tolerated dose \[MTD\]).
|
|---|---|
|
Overall Study
STARTED
|
47
|
|
Overall Study
Intent to Treat/Safety Population
|
47
|
|
Overall Study
Per Protocol Population
|
44
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
39
|
Reasons for withdrawal
| Measure |
MDNA55
Subjects received a single infusion of MDNA55 (via convection enhanced delivery) at concentrations ranging from 1.5 to 9.0 μg/mL. Total dose administered did not exceed 240 μg (the established maximum tolerated dose \[MTD\]).
|
|---|---|
|
Overall Study
Disease progression
|
31
|
|
Overall Study
Death
|
2
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
hospice,
|
1
|
|
Overall Study
did not receive drug due to catheters misplaced
|
1
|
Baseline Characteristics
Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma
Baseline characteristics by cohort
| Measure |
MDNA55
n=47 Participants
Subjects received a single infusion of MDNA55 (via convection enhanced delivery) at concentrations ranging from 1.5 to 9.0 μg/mL and volumes ranging from 12 to 66 mL (total dose between 18 to 240 mcg)
|
|---|---|
|
Age, Customized
Age (years)
|
56.7 years
STANDARD_DEVIATION 11.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
|
Ethnicity
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
|
Karnofsky Performance Score (KPS)
70 (caring for self, not capable of normal activity or work)
|
3 Participants
n=5 Participants
|
|
Karnofsky Performance Score (KPS)
80 (normal activity with some difficulty, some symptoms or signs)
|
20 Participants
n=5 Participants
|
|
Karnofsky Performance Score (KPS)
90 (capable of normal activity, few symptoms or signs of disease)
|
19 Participants
n=5 Participants
|
|
Karnofsky Performance Score (KPS)
100 (normal, no complaints, no signs of disease)
|
5 Participants
n=5 Participants
|
|
o6-methylguanine-DNA-methyltransferase (MGMT) Status
Methylated
|
18 Participants
n=5 Participants
|
|
o6-methylguanine-DNA-methyltransferase (MGMT) Status
Unmethylated
|
24 Participants
n=5 Participants
|
|
o6-methylguanine-DNA-methyltransferase (MGMT) Status
Not Available
|
5 Participants
n=5 Participants
|
|
Steroid Use
Yes
|
19 Participants
n=5 Participants
|
|
Steroid Use
No
|
13 Participants
n=5 Participants
|
|
Steroid Use
Not applicable
|
14 Participants
n=5 Participants
|
|
Steroid Use
Missing
|
1 Participants
n=5 Participants
|
|
Diagnostic method of Glioblastoma
CT
|
4 participants
n=5 Participants
|
|
Diagnostic method of Glioblastoma
MRI
|
32 participants
n=5 Participants
|
|
Diagnostic method of Glioblastoma
Biopsy
|
30 participants
n=5 Participants
|
|
Prior Glioblastoma treatment
Initial Surgery - Total Resection
|
37 participants
n=5 Participants
|
|
Prior Glioblastoma treatment
Initial Surgery - Partial Resection
|
4 participants
n=5 Participants
|
|
Prior Glioblastoma treatment
Initial Surgery - Other
|
6 participants
n=5 Participants
|
|
Prior Glioblastoma treatment
Additional Surgery - Resection
|
10 participants
n=5 Participants
|
|
Prior Glioblastoma treatment
Additional Surgery - Debulking
|
6 participants
n=5 Participants
|
|
Prior Glioblastoma treatment
Additional Surgery - Other
|
4 participants
n=5 Participants
|
|
Prior Glioblastoma treatment
Radiotherapy
|
46 participants
n=5 Participants
|
|
Prior Glioblastoma treatment
Temozolomide
|
46 participants
n=5 Participants
|
|
Prior Glioblastoma treatment
Other Chemotherapy
|
5 participants
n=5 Participants
|
|
Prior Glioblastoma treatment
Investigational
|
13 participants
n=5 Participants
|
|
Prior Glioblastoma treatment
Other
|
7 participants
n=5 Participants
|
|
Initial diagnosis to 1st relapse
|
12.98 months
STANDARD_DEVIATION 7.673 • n=5 Participants
|
|
Max tumor diameter at initial diagnosis
|
3.331 cm
STANDARD_DEVIATION 1.4310 • n=5 Participants
|
|
Number of prior relapse
1st relapse
|
37 Participants
n=5 Participants
|
|
Number of prior relapse
2nd relapse
|
10 Participants
n=5 Participants
|
|
Tumor volume at baseline
|
10.543 cm^3
STANDARD_DEVIATION 11.0621 • n=5 Participants
|
|
Maximum tumor diameter at baseline
|
3.160 cm
STANDARD_DEVIATION 1.1736 • n=5 Participants
|
|
Lymphocyte Count
|
0.991 10^9 cells/L
STANDARD_DEVIATION 0.3839 • n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until date of death from any cause. Subjects who were not known to have died at the time of the analysis were to be censored at the date of last contact.Population: Primary endpoint analysis was based on the ITT population. The null hypothesis was mOS of 8.0 months, based on a clinically-weighted average of published studies of FDA-approved therapies. ITT/Safety population: all subjects who signed an informed consent form and received any amount of study drug. Per-Protocol Population: all subjects in the ITT Population who had no major protocol violation during the study. Primary efficacy analysis was not performed for individual dose concentrations.
Primary endpoint analysis was based on the ITT population. The null hypothesis was mOS of 8.0 months, based on a clinically-weighted average of published studies of FDA-approved therapies versus the alternative hypothesis of 11.5 months.
Outcome measures
| Measure |
MDNA55 (ITT Analysis)
n=47 Participants
All subjects enrolled, received any amount of study drug
|
MDNA55 (PP Analysis)
n=44 Participants
In support of the primary efficacy analysis, evaluation of the primary endpoint was also conducted on the PP population.
|
|---|---|---|
|
Overall Survival (OS)
|
10.2 months
Interval 8.39 to 12.75
|
11.64 months
Interval 8.62 to 15.02
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Modified Intent-to-Treat Population (mITT): mITT population was used for secondary response analyses and consisted of all subjects who received any amount of study drug, had adequate imaging (at least 1 post-treatment scan), and had sufficient clinical data for ORR analysis.
ORR, determined by independent central review (per RANO-based criteria) Complete Response - Disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks. Partial Response - ≥50% decrease in sum of products of perpendicular diameters or ≥65% decrease in total volume of all measurable enhancing lesions compared with baseline, sustained for at least 4 weeks Progressive Disease - At least two sequential scans separated by at ≥4 weeks both exhibiting ≥25% increase in sum of products of perpendicular diameters or ≥40% increase in total volume of enhancing lesions. Stable Disease - Does not qualify for CR, PR, or PD as defined above
Outcome measures
| Measure |
MDNA55 (ITT Analysis)
n=41 Participants
All subjects enrolled, received any amount of study drug
|
MDNA55 (PP Analysis)
In support of the primary efficacy analysis, evaluation of the primary endpoint was also conducted on the PP population.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Modified Intent-to-Treat Population (mITT): mITT population was used for secondary response analyses and consisted of all subjects who received any amount of study drug, had adequate imaging (at least 1 post-treatment scan), and had sufficient clinical data for ORR analysis.
PFS, time from treatment until disease progression (per RANO-based criteria) or death Progressive Disease per RANO - At least two sequential scans separated by at ≥4 weeks both exhibiting ≥25% increase in sum of products of perpendicular diameters or ≥40% increase in total volume of enhancing lesions
Outcome measures
| Measure |
MDNA55 (ITT Analysis)
n=41 Participants
All subjects enrolled, received any amount of study drug
|
MDNA55 (PP Analysis)
In support of the primary efficacy analysis, evaluation of the primary endpoint was also conducted on the PP population.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
3.61 months
Interval 2.79 to 5.08
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Intent-to-Treat and Safety: ITT and Safety populations were identical and consisted of all subjects who signed an informed consent form and received any amount of study drug.
Number of Subjects with Serious adverse events with Frequency \>=5%
Outcome measures
| Measure |
MDNA55 (ITT Analysis)
n=47 Participants
All subjects enrolled, received any amount of study drug
|
MDNA55 (PP Analysis)
In support of the primary efficacy analysis, evaluation of the primary endpoint was also conducted on the PP population.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events
|
24 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Intent-to-Treat and Safety: ITT and Safety populations were identical and consisted of all subjects who signed an informed consent form and received any amount of study drug.
Incidence of Treatment-Emergent adverse events
Outcome measures
| Measure |
MDNA55 (ITT Analysis)
n=47 Participants
All subjects enrolled, received any amount of study drug
|
MDNA55 (PP Analysis)
In support of the primary efficacy analysis, evaluation of the primary endpoint was also conducted on the PP population.
|
|---|---|---|
|
Treatment Emergent Adverse Events
|
46 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 daysPopulation: Pharmacokinetic (PK) Population: Subjects who received the highest concentrations (6 μg/mL and 9 μg/mL) were analysed first. If all results were shown to be below lower limit of quantitation (LLOQ) of 0.37 ng/mL, consistent with historical data showing no evidence of systemic exposure with MDNA55, then no further subjects were to be analyzed. All subjects analyzed had levels of MDNA55 that were below lower limit of quantitation (LLOQ) of 0.37 ng/mL
Systemic exposure to MDNA55 is not expected following intratumoral infusion and circulating MDNA55 has not been detected in previous clinical studies. To continue to evaluate the potential of systemic exposure, plasma collected at screening (baseline), within 1 hour following infusion end time, \~3 hours following completion of infusion and then (after the \~3 hour sample collection) every 6 hours ± 2 hours until 24 hours and at Day 14. PK data will be presented for the PK population in listing format by subject and sample collection time point. PK parameters would only be analyzed if MDNA55 levels above LLOQ (0.37 ng/mL) were detected.
Outcome measures
| Measure |
MDNA55 (ITT Analysis)
n=28 Participants
All subjects enrolled, received any amount of study drug
|
MDNA55 (PP Analysis)
In support of the primary efficacy analysis, evaluation of the primary endpoint was also conducted on the PP population.
|
|---|---|---|
|
Level of MDNA55 in Peripheral Plasma
|
NA ng/mL
Standard Deviation NA
All MDNA55 levels below LLOQ
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Anti-Drug-Antibody (ADA) Population: ADA population included all subjects who received any dose of study drug and had a pre-treatment baseline blood sample and at least one post-treatment blood sample available for determination of ADA. Neutralizing antibody (NAb) titers were assessed in the ADA population as appropriate and applicable.
Number of participants that were ADA Positive and had Neutralizing Antibody
Outcome measures
| Measure |
MDNA55 (ITT Analysis)
n=46 Participants
All subjects enrolled, received any amount of study drug
|
MDNA55 (PP Analysis)
In support of the primary efficacy analysis, evaluation of the primary endpoint was also conducted on the PP population.
|
|---|---|---|
|
ADA Titer / Neutralizing Antibody Analysis
ADA positive
|
19 Participants
|
—
|
|
ADA Titer / Neutralizing Antibody Analysis
Neutralizing Antibody (NAb)
|
16 Participants
|
—
|
Adverse Events
MDNA55 (Overall)
MDNA55 (1.5 mcg/mL)
MDNA55 (3.0 mcg/mL)
MDNA55 (6.0 mcg/mL)
MDNA55 (9.0 mcg/mL)
Serious adverse events
| Measure |
MDNA55 (Overall)
n=47 participants at risk
Single infusion of MDNA55 administered via Convection Enhanced Delivery (CED) Dose conc. range 1.5 to 9.0 mcg/mL; total dose range 18 to 240 mcg
|
MDNA55 (1.5 mcg/mL)
n=18 participants at risk
Single infusion of MDNA55 administered via Convection Enhanced Delivery (CED) Dose conc. 1.5 mcg/mL
|
MDNA55 (3.0 mcg/mL)
n=9 participants at risk
Single infusion of MDNA55 administered via Convection Enhanced Delivery (CED) Dose conc. 3.0 mcg/mL
|
MDNA55 (6.0 mcg/mL)
n=6 participants at risk
Single infusion of MDNA55 administered via Convection Enhanced Delivery (CED) Dose conc. 6.0 mcg/mL
|
MDNA55 (9.0 mcg/mL)
n=13 participants at risk
Single infusion of MDNA55 administered via Convection Enhanced Delivery (CED) Dose conc. 9.0 mcg/mL
|
|---|---|---|---|---|---|
|
Nervous system disorders
Seizure
|
17.0%
8/47 • Number of events 9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
22.2%
4/18 • Number of events 5 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
33.3%
2/6 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Brain oedema
|
6.4%
3/47 • Number of events 4 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
15.4%
2/13 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Hydrocephalus
|
4.3%
2/47 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Hemiparesis
|
2.1%
1/47 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Partial seizures
|
2.1%
1/47 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
General disorders
Disease Progression
|
6.4%
3/47 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
15.4%
2/13 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Infections and infestations
Urinary tract infection
|
4.3%
2/47 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
2/47 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
2/18 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
General disorders
Asthenia
|
2.1%
1/47 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Cardiac disorders
Cardiac Arrest
|
2.1%
1/47 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Cerebral Haemorrhage
|
2.1%
1/47 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Cerebrovascular Accident
|
2.1%
1/47 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
General disorders
Complication of Device Insertion
|
2.1%
1/47 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Psychiatric disorders
Delirium
|
2.1%
1/47 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Gastrointestinal disorders
Dysphagia
|
2.1%
1/47 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Hemorrhage Intracranial
|
2.1%
1/47 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Hemiplegia
|
2.1%
1/47 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Metabolic Encephalopathy
|
2.1%
1/47 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Neurological Decompensation
|
4.3%
2/47 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Neurological Symptom
|
0.00%
0/47 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritumoral Oedema
|
0.00%
0/47 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Infections and infestations
Pneumonia
|
2.1%
1/47 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.1%
1/47 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Infections and infestations
Septic Shock
|
2.1%
1/47 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Somnolence
|
2.1%
1/47 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Status Epilepticus
|
4.3%
2/47 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
22.2%
2/9 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
Other adverse events
| Measure |
MDNA55 (Overall)
n=47 participants at risk
Single infusion of MDNA55 administered via Convection Enhanced Delivery (CED) Dose conc. range 1.5 to 9.0 mcg/mL; total dose range 18 to 240 mcg
|
MDNA55 (1.5 mcg/mL)
n=18 participants at risk
Single infusion of MDNA55 administered via Convection Enhanced Delivery (CED) Dose conc. 1.5 mcg/mL
|
MDNA55 (3.0 mcg/mL)
n=9 participants at risk
Single infusion of MDNA55 administered via Convection Enhanced Delivery (CED) Dose conc. 3.0 mcg/mL
|
MDNA55 (6.0 mcg/mL)
n=6 participants at risk
Single infusion of MDNA55 administered via Convection Enhanced Delivery (CED) Dose conc. 6.0 mcg/mL
|
MDNA55 (9.0 mcg/mL)
n=13 participants at risk
Single infusion of MDNA55 administered via Convection Enhanced Delivery (CED) Dose conc. 9.0 mcg/mL
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Agitation
|
8.5%
4/47 • Number of events 4 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
15.4%
2/13 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Investigations
Alanine aminotransferase increased
|
8.5%
4/47 • Number of events 6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
15.4%
2/13 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Psychiatric disorders
Anxiety
|
10.6%
5/47 • Number of events 5 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
2/18 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
15.4%
2/13 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Aphasia
|
25.5%
12/47 • Number of events 18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
22.2%
4/18 • Number of events 4 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
33.3%
3/9 • Number of events 4 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
33.3%
2/6 • Number of events 5 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
23.1%
3/13 • Number of events 5 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.6%
5/47 • Number of events 6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
33.3%
2/6 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Investigations
Blood albumin decreased
|
4.3%
2/47 • Number of events 5 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 4 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Investigations
Blood bilirubin increased
|
4.3%
2/47 • Number of events 5 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Investigations
Blood calcium decreased
|
4.3%
2/47 • Number of events 4 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Investigations
Blood lactate dehydrogenase increased
|
8.5%
4/47 • Number of events 4 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
2/18 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
15.4%
2/13 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Brain oedema
|
10.6%
5/47 • Number of events 6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
33.3%
3/9 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Cognitive disorder
|
8.5%
4/47 • Number of events 4 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
50.0%
3/6 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Psychiatric disorders
Confusional state
|
14.9%
7/47 • Number of events 7 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
22.2%
4/18 • Number of events 4 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
22.2%
2/9 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Gastrointestinal disorders
Constipation
|
17.0%
8/47 • Number of events 8 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
3/18 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
33.3%
2/6 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
15.4%
2/13 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.8%
6/47 • Number of events 6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
2/18 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
23.1%
3/13 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Psychiatric disorders
Confusion
|
4.3%
2/47 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Endocrine disorders
Cushingoid
|
4.3%
2/47 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Respiratory, thoracic and mediastinal disorders
Deep vein thrombosis
|
4.3%
2/47 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
15.4%
2/13 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
2/47 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Psychiatric disorders
Depression
|
10.6%
5/47 • Number of events 5 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
22.2%
2/9 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
23.1%
3/13 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Gastrointestinal disorders
Diarrhoea
|
8.5%
4/47 • Number of events 5 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
2/18 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Dizziness
|
8.5%
4/47 • Number of events 5 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
2/18 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
22.2%
2/9 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Dysarthria
|
8.5%
4/47 • Number of events 6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
2/18 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.3%
2/47 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Epilepsy
|
4.3%
2/47 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
2/18 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Extensor plantar response
|
4.3%
2/47 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Facial paralysis
|
4.3%
2/47 • Number of events 4 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Facial paresis
|
14.9%
7/47 • Number of events 7 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
2/18 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
22.2%
2/9 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
23.1%
3/13 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Injury, poisoning and procedural complications
Fall
|
10.6%
5/47 • Number of events 5 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
15.4%
2/13 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
General disorders
Fatigue
|
40.4%
19/47 • Number of events 23 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
44.4%
8/18 • Number of events 9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
33.3%
3/9 • Number of events 5 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
50.0%
3/6 • Number of events 4 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
38.5%
5/13 • Number of events 5 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
General disorders
Gait disturbance
|
14.9%
7/47 • Number of events 10 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
33.3%
3/9 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 4 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
23.1%
3/13 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Headache
|
38.3%
18/47 • Number of events 35 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
55.6%
10/18 • Number of events 10 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
22.2%
2/9 • Number of events 7 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
66.7%
4/6 • Number of events 13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
15.4%
2/13 • Number of events 5 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Hemiparesis
|
25.5%
12/47 • Number of events 17 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
22.2%
4/18 • Number of events 4 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
22.2%
2/9 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 4 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
38.5%
5/13 • Number of events 7 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.4%
3/47 • Number of events 5 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
2/18 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Vascular disorders
Hypertension
|
4.3%
2/47 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Hypoaesthesia
|
4.3%
2/47 • Number of events 5 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 4 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.9%
7/47 • Number of events 7 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
3/18 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
15.4%
2/13 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Vascular disorders
Hypotension
|
8.5%
4/47 • Number of events 4 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
3/18 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Psychiatric disorders
Insomnia
|
25.5%
12/47 • Number of events 13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
44.4%
4/9 • Number of events 4 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
66.7%
4/6 • Number of events 5 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
23.1%
3/13 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Psychiatric disorders
Irritability
|
4.3%
2/47 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Investigations
Lymphocyte count decreased
|
10.6%
5/47 • Number of events 13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
3/18 • Number of events 10 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Memory impairment
|
10.6%
5/47 • Number of events 6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
33.3%
2/6 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
15.4%
2/13 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
31.9%
15/47 • Number of events 18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
44.4%
8/18 • Number of events 9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
38.5%
5/13 • Number of events 6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Gastrointestinal disorders
Nausea
|
17.0%
8/47 • Number of events 10 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
3/18 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
22.2%
2/9 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
15.4%
2/13 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
General disorders
Oedema peripheral
|
6.4%
3/47 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
2/18 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
General disorders
Pain
|
6.4%
3/47 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.4%
3/47 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Paraesthesia
|
14.9%
7/47 • Number of events 7 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
2/18 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
22.2%
2/9 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
15.4%
2/13 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Partial seizures
|
4.3%
2/47 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
General disorders
Peripheral swelling
|
4.3%
2/47 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
15.4%
2/13 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Renal and urinary disorders
Pollakiuria
|
6.4%
3/47 • Number of events 4 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
2/47 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Pyramidal tract syndrome
|
17.0%
8/47 • Number of events 17 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
50.0%
3/6 • Number of events 9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
23.1%
3/13 • Number of events 5 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
General disorders
Pyrexia
|
4.3%
2/47 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Seizure
|
29.8%
14/47 • Number of events 17 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
22.2%
4/18 • Number of events 5 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
22.2%
2/9 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
83.3%
5/6 • Number of events 7 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
23.1%
3/13 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Simple partial seizures
|
4.3%
2/47 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
4.3%
2/47 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.3%
2/47 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/18 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
15.4%
2/13 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Nervous system disorders
Tremor
|
6.4%
3/47 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
7.7%
1/13 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Renal and urinary disorders
Urinary incontinence
|
4.3%
2/47 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
5.6%
1/18 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/13 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Infections and infestations
Urinary tract infection
|
14.9%
7/47 • Number of events 7 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
3/18 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/9 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
23.1%
3/13 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Eye disorders
Vision blurred
|
12.8%
6/47 • Number of events 6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
2/18 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
1/9 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
16.7%
1/6 • Number of events 1 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
15.4%
2/13 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
|
Gastrointestinal disorders
Vomiting
|
12.8%
6/47 • Number of events 8 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
11.1%
2/18 • Number of events 2 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
22.2%
2/9 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
0.00%
0/6 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
15.4%
2/13 • Number of events 3 • AEs were collected from catheter placement through 12 months post treatment or early withdrawal and followed until resolution, stabilization, data cut-off, or death. For subjects that withdraw from the study, SAEs that occur within 30 days of the date of discontinuation collected.
All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)
|
Additional Information
Rosemina Merchant - Chief Development Officer
Medicenna Therapeutics Inc
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place