Trial Outcomes & Findings for ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) (NCT NCT02946463)
NCT ID: NCT02946463
Last Updated: 2024-05-14
Results Overview
LDH is an indicator of intravascular hemolysis that occurs in participants with paroxysmal nocturnal hemoglobinuria (PNH). A decrease in LDH from above the upper limit of normal (ULN) to below the ULN indicates reduction (improvement) in hemolysis. Normalization of LDH levels (LDH-N) was LDH levels less than or equal to 1 x ULN, from Day 29 through Day 183. The ULN for LDH is 246 U/L.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
272 participants
Primary outcome timeframe
Day 29 through Day 183
Results posted on
2024-05-14
Participant Flow
24 adult and 2 pediatric participants rolled over from other Alexion ongoing studies of ravulizumab intravenous in participants with PNH into the extension period of this study and received weight-based doses of ravulizumab until end of study.
Participants were stratified into 6 groups based on transfusion history and LDH screening levels. Stratified participants were then randomly assigned in a 1:1 ratio to receive either ravulizumab or eculizumab in the 26-week Primary Evaluation Period.
Participant milestones
| Measure |
Ravulizumab/Ravulizumab
Participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg on Day 1. Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Day 15 and every 8 weeks thereafter for 26 weeks. After completion of the Primary Evaluation Period, all participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 5 years.
|
Eculizumab/Ravulizumab
Participants received 600 mg of eculizumab on Days 1, 8, 15, and 22, followed by 900 mg of eculizumab on Day 29 and every 2 weeks thereafter for 26 weeks. After completion of the Primary Evaluation Period, all participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 5 years.
|
Roll-Over Cohort: Ravulizumab - Adults
Participants in this group rolled over from other ongoing studies of ravulizumab intravenous in participants with PNH into the extension period of this study and received weight-based doses of ravulizumab for up to 5 years.
|
Roll-Over Cohort: Ravulizumab - Pediatrics
Participants in this group rolled over from other ongoing studies of ravulizumab intravenous in participants with PNH into the extension period of this study and received weight-based doses of ravulizumab for up to 5 years.
|
|---|---|---|---|---|
|
Primary Evaluation Period
STARTED
|
125
|
121
|
0
|
0
|
|
Primary Evaluation Period
Received at Least 1 Dose of Study Drug
|
125
|
121
|
0
|
0
|
|
Primary Evaluation Period
COMPLETED
|
125
|
119
|
0
|
0
|
|
Primary Evaluation Period
NOT COMPLETED
|
0
|
2
|
0
|
0
|
|
Extension Period
STARTED
|
124
|
119
|
24
|
2
|
|
Extension Period
Received at Least 1 Dose of Ravulizumab
|
124
|
119
|
24
|
2
|
|
Extension Period
COMPLETED
|
108
|
102
|
22
|
2
|
|
Extension Period
NOT COMPLETED
|
16
|
17
|
2
|
0
|
Reasons for withdrawal
| Measure |
Ravulizumab/Ravulizumab
Participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg on Day 1. Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Day 15 and every 8 weeks thereafter for 26 weeks. After completion of the Primary Evaluation Period, all participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 5 years.
|
Eculizumab/Ravulizumab
Participants received 600 mg of eculizumab on Days 1, 8, 15, and 22, followed by 900 mg of eculizumab on Day 29 and every 2 weeks thereafter for 26 weeks. After completion of the Primary Evaluation Period, all participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 5 years.
|
Roll-Over Cohort: Ravulizumab - Adults
Participants in this group rolled over from other ongoing studies of ravulizumab intravenous in participants with PNH into the extension period of this study and received weight-based doses of ravulizumab for up to 5 years.
|
Roll-Over Cohort: Ravulizumab - Pediatrics
Participants in this group rolled over from other ongoing studies of ravulizumab intravenous in participants with PNH into the extension period of this study and received weight-based doses of ravulizumab for up to 5 years.
|
|---|---|---|---|---|
|
Primary Evaluation Period
Physician Decision
|
0
|
1
|
0
|
0
|
|
Primary Evaluation Period
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Extension Period
Death
|
4
|
4
|
0
|
0
|
|
Extension Period
Withdrawal by Subject
|
4
|
3
|
0
|
0
|
|
Extension Period
Other than specified
|
2
|
3
|
2
|
0
|
|
Extension Period
Physician Decision
|
1
|
4
|
0
|
0
|
|
Extension Period
Pregnancy
|
3
|
1
|
0
|
0
|
|
Extension Period
Adverse Event
|
1
|
2
|
0
|
0
|
|
Extension Period
Lost to Follow-up
|
1
|
0
|
0
|
0
|
Baseline Characteristics
ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Baseline characteristics by cohort
| Measure |
Ravulizumab/Ravulizumab
n=125 Participants
Participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg on Day 1. Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Day 15 and every 8 weeks thereafter for 26 weeks. After completion of the Primary Evaluation Period, all participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 5 years.
|
Eculizumab/Ravulizumab
n=121 Participants
Participants received 600 mg of eculizumab on Days 1, 8, 15, and 22, followed by 900 mg of eculizumab on Day 29 and every 2 weeks thereafter for 26 weeks. After completion of the Primary Evaluation Period, all participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 5 years.
|
Roll-Over Cohort: Ravulizumab - Adults
n=24 Participants
Participants in this group rolled over from other ongoing studies of ravulizumab intravenous in participants with PNH into the extension period of this study and received weight-based doses of ravulizumab for up to 5 years.
|
Roll-Over Cohort: Ravulizumab - Pediatrics
n=2 Participants
Participants in this group rolled over from other ongoing studies of ravulizumab intravenous in participants with PNH into the extension period of this study and received weight-based doses of ravulizumab for up to 5 years.
|
Total
n=272 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
111 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
236 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
125 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
147 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
116 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
218 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
72 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
107 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 29 through Day 183Population: Full Analysis Set: All participants who received at least 1 dose of study drug (ravulizumab or eculizumab) and had at least 1 efficacy assessment after the first infusion of study drug.
LDH is an indicator of intravascular hemolysis that occurs in participants with paroxysmal nocturnal hemoglobinuria (PNH). A decrease in LDH from above the upper limit of normal (ULN) to below the ULN indicates reduction (improvement) in hemolysis. Normalization of LDH levels (LDH-N) was LDH levels less than or equal to 1 x ULN, from Day 29 through Day 183. The ULN for LDH is 246 U/L.
Outcome measures
| Measure |
Ravulizumab
n=125 Participants
Participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg on Day 1. Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Day 15 and every 8 weeks thereafter for 26 weeks.
|
Eculizumab
n=121 Participants
Participants received 600 mg of eculizumab on Days 1, 8, 15, and 22, followed by 900 mg of eculizumab on Day 29 and every 2 weeks thereafter for 26 weeks.
|
|---|---|---|
|
Proportion Of Participants With Normalization Of Lactate Dehydrogenase (LDH) Levels
|
0.536 proportion of participants
Interval 0.459 to 0.612
|
0.494 proportion of participants
Interval 0.417 to 0.57
|
PRIMARY outcome
Timeframe: Baseline through Day 183Population: Full Analysis Set: All participants who received at least 1 dose of study drug (ravulizumab or eculizumab) and had at least 1 efficacy assessment after the first infusion of study drug.
Transfusion avoidance was defined as the percentage of participants who remained transfusion free and did not require a transfusion per protocol-specified guidelines through Day 183.
Outcome measures
| Measure |
Ravulizumab
n=125 Participants
Participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg on Day 1. Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Day 15 and every 8 weeks thereafter for 26 weeks.
|
Eculizumab
n=121 Participants
Participants received 600 mg of eculizumab on Days 1, 8, 15, and 22, followed by 900 mg of eculizumab on Day 29 and every 2 weeks thereafter for 26 weeks.
|
|---|---|---|
|
Percentage Of Participants Who Achieved Transfusion Avoidance (TA)
|
73.6 percentage of participants
Interval 65.87 to 81.33
|
66.1 percentage of participants
Interval 57.68 to 74.55
|
SECONDARY outcome
Timeframe: Baseline through Day 183Population: Full Analysis Set: All participants who received at least 1 dose of study drug (ravulizumab or eculizumab) and had at least 1 efficacy assessment after the first infusion of study drug.
Breakthrough hemolysis was defined as at least 1 new or worsening symptom or sign of intravascular hemolysis (fatigue, hemoglobinuria, abdominal pain, shortness of breath \[dyspnea\], anemia \[hemoglobin \<10 gram/deciliter (g/dL)\], major adverse vascular event \[MAVE, including thrombosis\], dysphagia, or erectile dysfunction) in the presence of elevated LDH ≥2 × ULN, after prior LDH reduction to \<1.5 × ULN on therapy.
Outcome measures
| Measure |
Ravulizumab
n=125 Participants
Participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg on Day 1. Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Day 15 and every 8 weeks thereafter for 26 weeks.
|
Eculizumab
n=121 Participants
Participants received 600 mg of eculizumab on Days 1, 8, 15, and 22, followed by 900 mg of eculizumab on Day 29 and every 2 weeks thereafter for 26 weeks.
|
|---|---|---|
|
Percentage Of Participants With Breakthrough Hemolysis (BTH)
|
4.0 percentage of participants
Interval 0.56 to 7.44
|
10.7 percentage of participants
Interval 5.23 to 16.26
|
SECONDARY outcome
Timeframe: Baseline, Day 183Population: Full Analysis Set: All participants who received at least 1 dose of study drug (ravulizumab or eculizumab) and had at least 1 efficacy assessment after the first infusion of study drug.
Baseline is defined as the average of all available assessments of LDH levels prior to first study drug dose. Estimates are based on Mixed Model for Repeated Measures (MMRM) that includes treatment group, history of transfusion (as a categorical variable based on the stratification factor levels) and baseline LDH level (as a continuous variable), study visit and study visit by treatment group interaction. An unstructured covariance structure was used.
Outcome measures
| Measure |
Ravulizumab
n=125 Participants
Participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg on Day 1. Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Day 15 and every 8 weeks thereafter for 26 weeks.
|
Eculizumab
n=121 Participants
Participants received 600 mg of eculizumab on Days 1, 8, 15, and 22, followed by 900 mg of eculizumab on Day 29 and every 2 weeks thereafter for 26 weeks.
|
|---|---|---|
|
Percent Change From Baseline In LDH Levels
|
-76.84 percent change
Interval -79.96 to -73.73
|
-76.02 percent change
Interval -79.2 to -72.83
|
SECONDARY outcome
Timeframe: Baseline, Day 183Population: Full Analysis Set: All participants who received at least 1 dose of study drug (ravulizumab or eculizumab) and had at least 1 efficacy assessment after the first infusion of study drug.
FACIT-Fatigue score ranges from 0 to 52, with a higher score indicating less fatigue. Baseline is defined as the last non-missing value prior to first dose of study drug. Estimates are based on MMRM that includes treatment group, the observed stratification randomization indicators (history of transfusion and LDH) and baseline FACIT-Fatigue level, study visit, and study visit by treatment group interaction. An unstructured covariance structure was used.
Outcome measures
| Measure |
Ravulizumab
n=125 Participants
Participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg on Day 1. Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Day 15 and every 8 weeks thereafter for 26 weeks.
|
Eculizumab
n=121 Participants
Participants received 600 mg of eculizumab on Days 1, 8, 15, and 22, followed by 900 mg of eculizumab on Day 29 and every 2 weeks thereafter for 26 weeks.
|
|---|---|---|
|
Change From Baseline In Quality Of Life As Assessed By The Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue
|
7.07 units on a scale
Interval 5.55 to 8.6
|
6.40 units on a scale
Interval 4.85 to 7.96
|
SECONDARY outcome
Timeframe: Baseline through Day 183Population: Full Analysis Set: All participants who received at least 1 dose of study drug (ravulizumab or eculizumab) and had at least 1 efficacy assessment after the first infusion of study drug.
Stabilized hemoglobin was defined as avoidance of a ≥2 g/dL decrease in hemoglobin level from baseline in the absence of transfusion through Day 183.
Outcome measures
| Measure |
Ravulizumab
n=125 Participants
Participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg on Day 1. Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Day 15 and every 8 weeks thereafter for 26 weeks.
|
Eculizumab
n=121 Participants
Participants received 600 mg of eculizumab on Days 1, 8, 15, and 22, followed by 900 mg of eculizumab on Day 29 and every 2 weeks thereafter for 26 weeks.
|
|---|---|---|
|
Percentage Of Participants With Stabilized Hemoglobin Levels
|
68.0 percentage of participants
Interval 59.82 to 76.18
|
64.5 percentage of participants
Interval 55.93 to 72.99
|
Adverse Events
Ravulizumab: Primary Evaluation
Serious events: 11 serious events
Other events: 87 other events
Deaths: 0 deaths
Eculizumab: Primary Evaluation
Serious events: 9 serious events
Other events: 86 other events
Deaths: 0 deaths
Ravulizumab/Ravulizumab: Extension Period
Serious events: 52 serious events
Other events: 102 other events
Deaths: 4 deaths
Eculizumab/Ravulizumab: Extension Period
Serious events: 43 serious events
Other events: 100 other events
Deaths: 4 deaths
Ravulizumab-Adults
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Ravulizumab-Pediatrics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ravulizumab: Primary Evaluation
n=125 participants at risk
Participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg on Day 1. Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Day 15 and every 8 weeks thereafter for 26 weeks.
|
Eculizumab: Primary Evaluation
n=121 participants at risk
Participants received 600 mg of eculizumab on Days 1, 8, 15, and 22, followed by 900 mg of eculizumab on Day 29 and every 2 weeks thereafter for 26 weeks.
|
Ravulizumab/Ravulizumab: Extension Period
n=124 participants at risk
After completion of the Primary Evaluation Period, all participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 5 years.
|
Eculizumab/Ravulizumab: Extension Period
n=119 participants at risk
After completion of the Primary Evaluation Period, all participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 5 years.
|
Ravulizumab-Adults
n=24 participants at risk
Participants in this group rolled over from other ongoing studies of ravulizumab intravenous in participants with PNH into the extension period of this study and received weight-based doses of ravulizumab for up to 5 years.
|
Ravulizumab-Pediatrics
n=2 participants at risk
Participants in this group rolled over from other ongoing studies of ravulizumab intravenous in participants with PNH into the extension period of this study and received weight-based doses of ravulizumab for up to 5 years.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.80%
1/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.6%
7/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
1.7%
2/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.80%
1/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
4.0%
5/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
4.2%
1/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.80%
1/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.80%
1/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Cardiac disorders
Left ventricular failure
|
0.80%
1/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.80%
1/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.83%
1/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
General disorders
Pyrexia
|
0.80%
1/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
1.7%
2/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
3.2%
4/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
2.5%
3/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Abscess limb
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.83%
1/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.83%
1/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Infection
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.83%
1/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Leptospirosis
|
0.80%
1/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.83%
1/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
4.0%
5/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.0%
6/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Systemic infection
|
0.80%
1/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.83%
1/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
1.6%
2/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.83%
1/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
1.7%
1/60 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/52 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Renal and urinary disorders
Paroxysmal nocturnal haemoglobinuria
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.83%
1/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Renal and urinary disorders
Renal colic
|
0.80%
1/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Vascular disorders
Deep vein thrombosis
|
0.80%
1/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Blood and lymphatic system disorders
Breakthrough haemolysis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
1.6%
2/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
3.2%
4/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
1.7%
2/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
1.6%
2/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
2.5%
3/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
2.5%
3/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Congenital, familial and genetic disorders
Branchial cyst
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Gastrointestinal disorders
Gastric varices
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
General disorders
Chest discomfort
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
3.4%
4/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
1.6%
2/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
4.2%
1/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Immune system disorders
Allergy to vaccine
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Chikungunya virus infection
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
COVID-19
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
4.8%
6/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
2.5%
3/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
2.4%
3/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
1.7%
2/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Cystitis escherichia
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Dengue fever
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Endometritis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Erysipelas
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
1.6%
2/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Fungal endocarditis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Furuncle
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
1.6%
2/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Influenza
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Intracranial infection
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Meningococcal sepsis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Sepsis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
1.6%
2/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Septic shock
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
1.7%
2/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
1.7%
2/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.80%
1/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Metabolism and nutrition disorders
Haemochromatosis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
1.7%
2/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sinonasal papilloma
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Nervous system disorders
Cerebral venous thrombosis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Nervous system disorders
Headache
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Nervous system disorders
Migraine
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
1.6%
2/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.84%
1/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
Other adverse events
| Measure |
Ravulizumab: Primary Evaluation
n=125 participants at risk
Participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg on Day 1. Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Day 15 and every 8 weeks thereafter for 26 weeks.
|
Eculizumab: Primary Evaluation
n=121 participants at risk
Participants received 600 mg of eculizumab on Days 1, 8, 15, and 22, followed by 900 mg of eculizumab on Day 29 and every 2 weeks thereafter for 26 weeks.
|
Ravulizumab/Ravulizumab: Extension Period
n=124 participants at risk
After completion of the Primary Evaluation Period, all participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 5 years.
|
Eculizumab/Ravulizumab: Extension Period
n=119 participants at risk
After completion of the Primary Evaluation Period, all participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 5 years.
|
Ravulizumab-Adults
n=24 participants at risk
Participants in this group rolled over from other ongoing studies of ravulizumab intravenous in participants with PNH into the extension period of this study and received weight-based doses of ravulizumab for up to 5 years.
|
Ravulizumab-Pediatrics
n=2 participants at risk
Participants in this group rolled over from other ongoing studies of ravulizumab intravenous in participants with PNH into the extension period of this study and received weight-based doses of ravulizumab for up to 5 years.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
7/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.8%
7/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
8.1%
10/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
10.1%
12/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
8.3%
2/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
10/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
4.1%
5/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
11.3%
14/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
10.9%
13/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Gastrointestinal disorders
Nausea
|
8.8%
11/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
8.3%
10/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
6.5%
8/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
9.2%
11/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
General disorders
Pyrexia
|
4.8%
6/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
9.1%
11/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
17.7%
22/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
15.1%
18/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
8.3%
2/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
11/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
16.5%
20/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
11.3%
14/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
21.8%
26/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Upper respiratory tract infection
|
10.4%
13/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.8%
7/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
24.2%
30/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
21.0%
25/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.2%
9/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
6.6%
8/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.8%
11/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
9.1%
11/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
13.7%
17/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
10.1%
12/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.4%
8/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.0%
6/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
9.7%
12/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
9.2%
11/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
8.3%
2/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.2%
9/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
7.4%
9/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
3.2%
4/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.9%
7/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.2%
9/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.0%
6/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Nervous system disorders
Dizziness
|
7.2%
9/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.8%
7/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
3.2%
4/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
7.6%
9/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Nervous system disorders
Headache
|
36.0%
45/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
33.1%
40/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
12.9%
16/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
16.8%
20/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
8.3%
2/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
4/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
6.6%
8/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
11.3%
14/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
15.1%
18/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.4%
8/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.0%
6/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
3/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.0%
6/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
3.2%
4/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
8.4%
10/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.6%
7/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
2.5%
3/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
7.3%
9/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
2.5%
3/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
6.5%
8/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
3.4%
4/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Cardiac disorders
Palpitations
|
5.6%
7/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
1.7%
2/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
8.1%
10/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
4.2%
5/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
8.1%
10/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
4.2%
5/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
5/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.0%
6/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
6.5%
8/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
8.4%
10/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.6%
7/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
3.4%
4/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
General disorders
Asthenia
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
16.7%
4/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
General disorders
Chest pain
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
6.5%
8/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
2.5%
3/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
General disorders
Fatigue
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
4.0%
5/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
8.4%
10/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
2.4%
3/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.9%
7/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
COVID-19
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
15.3%
19/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
13.4%
16/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
37.5%
9/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Cystitis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
6.5%
8/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
3.4%
4/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
2.4%
3/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
7.6%
9/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Influenza
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
7.3%
9/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
9.2%
11/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
4.0%
5/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.0%
6/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
6.5%
8/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
2.5%
3/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
7.3%
9/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
6.7%
8/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Investigations
C-reactive protein increased
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
1.6%
2/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.0%
6/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
9.7%
12/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
3.4%
4/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Psychiatric disorders
Insomnia
|
1.6%
2/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.0%
6/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
8.9%
11/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.0%
6/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
3.2%
4/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.9%
7/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
4/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.0%
6/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.81%
1/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.9%
7/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
|
Vascular disorders
Hypertension
|
0.00%
0/125 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/121 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
5.6%
7/124 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
3.4%
4/119 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/24 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
0.00%
0/2 • Baseline up to Day 2045
Treatment-emergent adverse events (TEAEs) reported below include TEAEs that occurred during or after first infusion of study treatment up to Day 2045 (end of study).
|
Additional Information
Alexion Pharmaceuticals Inc.
Alexion Pharmaceuticals Inc.
Phone: 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place