Trial Outcomes & Findings for An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) (NCT NCT04145531)
NCT ID: NCT04145531
Last Updated: 2023-11-18
Results Overview
The response rate was defined as the number (proportion) of patients with the last 72-hour nadir serum asparaginase activity (NSAA) level ≥ 0.1 IU/mL during the first course of IM JZP-458. Blood samples were collected for serum asparaginase activity level determination.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
229 participants
Primary outcome timeframe
Baseline up to 2 weeks
Results posted on
2023-11-18
Participant Flow
A total of 229 participants who met all inclusion and no exclusion criteria were enrolled in the study. One participant did not receive treatment; 228 participants were included in the Safety Analysis Set and 224 participants were included in the Efficacy Analysis Set. The data presented are based on the final database cut (22 November 2022).
Participant milestones
| Measure |
Part A: JZP-458 IM 25 mg/m^2 (MWF)
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
|
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
|---|---|---|---|---|
|
Part A
STARTED
|
33
|
83
|
51
|
0
|
|
Part A
Safety Analysis Set
|
33
|
83
|
51
|
0
|
|
Part A
Efficacy Analysis Set
|
32
|
83
|
50
|
0
|
|
Part A
COMPLETED
|
27
|
62
|
39
|
0
|
|
Part A
NOT COMPLETED
|
6
|
21
|
12
|
0
|
|
Part B
STARTED
|
0
|
0
|
0
|
62
|
|
Part B
Safety Analysis Set
|
0
|
0
|
0
|
61
|
|
Part B
Efficacy Analysis Set
|
0
|
0
|
0
|
59
|
|
Part B
COMPLETED
|
0
|
0
|
0
|
27
|
|
Part B
NOT COMPLETED
|
0
|
0
|
0
|
35
|
Reasons for withdrawal
| Measure |
Part A: JZP-458 IM 25 mg/m^2 (MWF)
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
|
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
|---|---|---|---|---|
|
Part A
Adverse Event
|
2
|
12
|
6
|
0
|
|
Part A
Death
|
1
|
2
|
0
|
0
|
|
Part A
Physician Decision
|
2
|
5
|
2
|
0
|
|
Part A
Progressive disease
|
0
|
2
|
1
|
0
|
|
Part A
Protocol deviation
|
0
|
0
|
1
|
0
|
|
Part A
Withdrawal by parent or guardian
|
1
|
0
|
0
|
0
|
|
Part A
Withdrawal by participant
|
0
|
0
|
1
|
0
|
|
Part A
Other
|
0
|
0
|
1
|
0
|
|
Part B
Adverse Event
|
0
|
0
|
0
|
21
|
|
Part B
Physician Decision
|
0
|
0
|
0
|
7
|
|
Part B
Progressive disease
|
0
|
0
|
0
|
1
|
|
Part B
Recurrent disease
|
0
|
0
|
0
|
1
|
|
Part B
Withdrawal by parent or guardian
|
0
|
0
|
0
|
3
|
|
Part B
Withdrawal by participant
|
0
|
0
|
0
|
1
|
|
Part B
Other
|
0
|
0
|
0
|
1
|
Baseline Characteristics
An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)
Baseline characteristics by cohort
| Measure |
Part A: JZP-458 IM 25 mg/m^2 (MWF)
n=33 Participants
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
|
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
n=83 Participants
Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
n=51 Participants
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
n=61 Participants
Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=39 Participants
|
79 Participants
n=41 Participants
|
46 Participants
n=35 Participants
|
54 Participants
n=31 Participants
|
204 Participants
n=146 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
24 Participants
n=146 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age, Continuous
|
11.5 years
STANDARD_DEVIATION 7.11 • n=39 Participants
|
9.0 years
STANDARD_DEVIATION 5.08 • n=41 Participants
|
11.3 years
STANDARD_DEVIATION 5.41 • n=35 Participants
|
10.4 years
STANDARD_DEVIATION 6.30 • n=31 Participants
|
10.3 years
STANDARD_DEVIATION 5.86 • n=146 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=39 Participants
|
28 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
25 Participants
n=31 Participants
|
89 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=39 Participants
|
55 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
36 Participants
n=31 Participants
|
139 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
5 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
10 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
24 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=39 Participants
|
58 Participants
n=41 Participants
|
33 Participants
n=35 Participants
|
43 Participants
n=31 Participants
|
158 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
29 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 2 weeksPopulation: Response rates were assessed in the Efficacy Analysis Set in participants with available data.
The response rate was defined as the number (proportion) of patients with the last 72-hour nadir serum asparaginase activity (NSAA) level ≥ 0.1 IU/mL during the first course of IM JZP-458. Blood samples were collected for serum asparaginase activity level determination.
Outcome measures
| Measure |
Part A: JZP-458 IM 25 mg/m^2 (MWF)
n=28 Participants
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
|
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
n=77 Participants
Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
n=49 Participants
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
n=50 Participants
Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
|---|---|---|---|---|
|
Response Rate During the First Course of JZP-458 Administration
|
18 Participants
|
70 Participants
|
44 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 monthsPopulation: Safety events were assessed in the Safety Analysis Set.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered related to study drug. AEs were classified by the Investigator using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Outcome measures
| Measure |
Part A: JZP-458 IM 25 mg/m^2 (MWF)
n=33 Participants
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
|
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
n=83 Participants
Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
n=51 Participants
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
n=61 Participants
Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)
|
32 Participants
|
83 Participants
|
49 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 2 weeksPopulation: Nadir serum asparaginase activity levels were assessed in the Efficacy Analysis Set.
Blood samples were collected for serum asparaginase activity level determination.
Outcome measures
| Measure |
Part A: JZP-458 IM 25 mg/m^2 (MWF)
n=32 Participants
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
|
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
n=83 Participants
Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
n=49 Participants
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
n=59 Participants
Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Last 48-hour NSAA Level ≥ 0.1 IU/mL During The First Course (6 Doses) of JZP-458 Administration
|
31 Participants
|
82 Participants
|
47 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 2 weeksPopulation: Nadir serum asparaginase activity levels were assessed in the Efficacy Analysis Set in participants with available data.
Blood samples were collected for serum asparaginase activity level determination.
Outcome measures
| Measure |
Part A: JZP-458 IM 25 mg/m^2 (MWF)
n=32 Participants
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
|
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
n=83 Participants
Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
n=49 Participants
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
n=59 Participants
Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Last NSAA Levels ≥ 0.4 IU/mL During The First Course (6 Doses) of JZP-458 Administration
Last 48 hours
|
16 Participants
|
65 Participants
|
32 Participants
|
10 Participants
|
|
Number of Participants With Last NSAA Levels ≥ 0.4 IU/mL During The First Course (6 Doses) of JZP-458 Administration
Last 72 hours
|
1 Participants
|
20 Participants
|
23 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 weeks (6 doses)Population: Serum asparaginase activity levels were assessed in participants with available data in the Efficacy Analysis Set.
Serum asparaginase levels serve as a surrogate marker for asparagine depletion. Mean serum asparaginase activity levels in Course 1 are reported.
Outcome measures
| Measure |
Part A: JZP-458 IM 25 mg/m^2 (MWF)
n=32 Participants
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
|
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
n=83 Participants
Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
n=49 Participants
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
n=59 Participants
Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
|---|---|---|---|---|
|
Mean Serum Asparaginase Activity Levels in First Course of JZP-458 Administration
Last 48 hours
|
0.45 IU/mL
Interval 0.37 to 0.53
|
0.88 IU/mL
Interval 0.76 to 1.01
|
0.66 IU/mL
Interval 0.54 to 0.77
|
0.25 IU/mL
Interval 0.2 to 0.29
|
|
Mean Serum Asparaginase Activity Levels in First Course of JZP-458 Administration
Last 72 hours
|
0.16 IU/mL
Interval 0.12 to 0.19
|
0.33 IU/mL
Interval 0.28 to 0.39
|
0.47 IU/mL
Interval 0.35 to 0.59
|
0.10 IU/mL
Interval 0.07 to 0.13
|
SECONDARY outcome
Timeframe: Baseline up to 30 days (ADA- samples) after last dose of last course and up to 6 months (ADA+ samples) after last dose of last course, up to approximately 2 years 7 monthsPopulation: Immunogenicity was assessed in the Safety Analysis Set.
Blood samples were collected for immunogenicity analysis. Anti-drug antibody positive (ADA+) participants were those with a positive result on the first test and also a positive result on the confirmatory test. Anti-drug antibody negative (ADA-) participants had a negative result on the first test.
Outcome measures
| Measure |
Part A: JZP-458 IM 25 mg/m^2 (MWF)
n=33 Participants
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
|
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
n=83 Participants
Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
n=51 Participants
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
n=61 Participants
Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
|---|---|---|---|---|
|
Number of Participants Who Are Anti-drug Antibody Positive or Negative Against JZP-458
Overall confirmed ADA+
|
16 Participants
|
41 Participants
|
25 Participants
|
34 Participants
|
|
Number of Participants Who Are Anti-drug Antibody Positive or Negative Against JZP-458
Overall ADA-
|
17 Participants
|
42 Participants
|
26 Participants
|
27 Participants
|
Adverse Events
Part A: JZP-458 IM 25 mg/m^2 (MWF)
Serious events: 20 serious events
Other events: 31 other events
Deaths: 1 deaths
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
Serious events: 57 serious events
Other events: 81 other events
Deaths: 2 deaths
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
Serious events: 34 serious events
Other events: 48 other events
Deaths: 0 deaths
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
Serious events: 40 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: JZP-458 IM 25 mg/m^2 (MWF)
n=33 participants at risk
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
|
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
n=83 participants at risk
Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
n=51 participants at risk
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
n=61 participants at risk
Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
27.3%
9/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
28.9%
24/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
39.2%
20/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
23.0%
14/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.6%
3/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.4%
2/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Blood and lymphatic system disorders
Methaemoglobinaemia
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.4%
2/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Cardiac disorders
Tachycardia
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Cardiac disorders
Cardiac failure
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Stomatitis
|
9.1%
3/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.8%
4/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.8%
4/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
9.6%
8/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
9.8%
6/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Nausea
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.2%
6/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.6%
4/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.6%
3/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.8%
4/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Colitis
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.4%
2/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
General disorders
Pyrexia
|
9.1%
3/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
9.6%
8/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
15.7%
8/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.9%
3/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
General disorders
Chills
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
General disorders
Pain
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Immune system disorders
Drug hypersensitivity
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.8%
4/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
8.2%
5/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.6%
3/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Sepsis
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.0%
5/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
11.8%
6/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.9%
3/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.4%
2/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Corona virus infection
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.4%
2/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Skin infection
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Soft tissue infection
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Citrobacter infection
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Necrotising fasciitis
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Otitis media
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Wound infection
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Injury, poisoning and procedural complications
Anaphylactic transfusion reaction
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.9%
3/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Platelet count decreased
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Weight decreased
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Amylase increased
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Blood creatine increase
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Lipase increased
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Shigella test positive
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Blood culture positive
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Drug clearance decreased
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
3/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
8.4%
7/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
9.8%
5/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.4%
2/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
8.2%
5/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Metabolism and nutrition disorders
Acidosis
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma recurrent
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Histiocytic sarcoma
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.4%
2/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Seizure
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.4%
2/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Leukoencephalopathy
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Presyncope
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Superior sagittal sinus thrombosis
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Hyperammonaemic encephalopathy
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.8%
4/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.4%
2/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.4%
2/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Vascular disorders
Hypotension
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
Other adverse events
| Measure |
Part A: JZP-458 IM 25 mg/m^2 (MWF)
n=33 participants at risk
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
|
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
n=83 participants at risk
Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
n=51 participants at risk
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
n=61 participants at risk
Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Dysuria
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.0%
5/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.2%
5/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
13.3%
11/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
17.6%
9/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
11.5%
7/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.4%
2/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.9%
3/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
8.4%
7/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.8%
4/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.9%
3/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
10.8%
9/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.8%
4/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.9%
3/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
12.0%
10/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
11.8%
6/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
14.8%
9/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.1%
4/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
12.0%
10/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.8%
4/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.6%
4/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.1%
4/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.8%
4/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.8%
4/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.9%
3/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.2%
6/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.2%
6/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.6%
3/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
9.8%
5/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.2%
6/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.0%
5/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
9.6%
8/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
9.8%
6/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Vascular disorders
Flushing
|
12.1%
4/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.8%
4/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Vascular disorders
Hypertension
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.2%
6/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
15.7%
8/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Vascular disorders
Hypotension
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.2%
6/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
39.4%
13/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
56.6%
47/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
54.9%
28/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
36.1%
22/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.0%
5/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.8%
4/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Cardiac disorders
Sinus bradycardia
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Cardiac disorders
Sinus tachycardia
|
15.2%
5/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
20.5%
17/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
13.7%
7/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.6%
4/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Eye disorders
Periorbital oedema
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Eye disorders
Vision blurred
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.6%
3/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.2%
5/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
30.1%
25/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
25.5%
13/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
14.8%
9/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux
|
12.1%
4/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.9%
3/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
3/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.6%
3/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.9%
3/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Anal fissure
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Constipation
|
12.1%
4/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
15.7%
13/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
15.7%
8/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
19.7%
12/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.1%
4/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
27.7%
23/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
23.5%
12/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
18.0%
11/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.2%
6/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.6%
4/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Nausea
|
24.2%
8/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
33.7%
28/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
33.3%
17/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
45.9%
28/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Oral pain
|
9.1%
3/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.4%
2/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.4%
2/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Stomatitis
|
18.2%
6/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
26.5%
22/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
27.5%
14/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
27.9%
17/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Toothache
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Gastrointestinal disorders
Vomiting
|
36.4%
12/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
47.0%
39/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
29.4%
15/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
62.3%
38/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
General disorders
Asthenia
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
General disorders
Catheter site pain
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.8%
4/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
9.8%
5/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
General disorders
Catheter site rash
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.4%
2/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.6%
4/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
General disorders
Chills
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.2%
6/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
General disorders
Fatigue
|
30.3%
10/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
38.6%
32/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
25.5%
13/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
24.6%
15/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
General disorders
Injection site pain
|
9.1%
3/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.8%
4/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
General disorders
Injection site reaction
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.4%
2/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.8%
4/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
General disorders
Pain
|
12.1%
4/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.2%
6/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
General disorders
Pyrexia
|
24.2%
8/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
37.3%
31/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
21.6%
11/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
19.7%
12/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Immune system disorders
Drug hypersensitivity
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.8%
4/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
14.8%
9/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Corona virus infection
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.0%
5/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.9%
3/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Enterocolitis infectious
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Paronychia
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
3/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
8.4%
7/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
14.8%
9/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.2%
6/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.8%
4/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Lymphocyte count decreased
|
24.2%
8/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
25.3%
21/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
17.6%
9/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
13.1%
8/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.4%
2/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Neutrophil count decreased
|
42.4%
14/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
41.0%
34/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
49.0%
25/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
18.0%
11/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
12.1%
4/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
9.6%
8/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
15.7%
8/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.9%
3/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
8.4%
7/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Alanine aminotransferase increased
|
18.2%
6/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
34.9%
29/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
19.6%
10/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
29.5%
18/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Antithrombin III decreased
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Aspartate aminotransferase increased
|
15.2%
5/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
28.9%
24/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
11.8%
6/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
21.3%
13/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.0%
5/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Blood bilirubin increased
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
14.5%
12/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.8%
4/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
8.2%
5/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Blood cholesterol increased
|
12.1%
4/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.6%
3/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
9.6%
8/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
8.2%
5/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Blood fibrinogen decreased
|
9.1%
3/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.6%
3/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Dizziness
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.8%
4/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.8%
4/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
9.8%
6/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
CD4 lymphocytes decreased
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Haematocrit decreased
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Haemoglobin decreased
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Platelet count decreased
|
39.4%
13/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
43.4%
36/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
49.0%
25/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
21.3%
13/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Weight decreased
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
15.7%
13/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
17.6%
9/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
8.2%
5/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
Weight increased
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.9%
3/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Investigations
White blood cell count decreased
|
36.4%
12/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
30.1%
25/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
23.5%
12/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
18.0%
11/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.2%
7/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
33.7%
28/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
29.4%
15/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
24.6%
15/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
3/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
10.8%
9/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
8.2%
5/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
21.2%
7/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
16.9%
14/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
13.7%
7/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
14.8%
9/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.6%
3/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.2%
6/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
9.1%
3/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
8.4%
7/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
11.8%
6/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
8.2%
5/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
12.1%
4/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
14.5%
12/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
9.8%
6/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.1%
4/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
10.8%
9/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.8%
4/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.6%
4/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
9.1%
3/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.2%
6/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
8.2%
5/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.1%
3/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
16.9%
14/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
21.6%
11/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
13.1%
8/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.0%
5/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
8.4%
7/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.8%
4/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
8.2%
5/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.0%
5/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.2%
5/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
10.8%
9/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.8%
4/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
8.2%
5/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
27.3%
9/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
26.5%
22/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
13.7%
7/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
16.4%
10/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
8.4%
7/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.4%
2/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.1%
3/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.9%
3/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.9%
3/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.6%
3/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.9%
3/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
24.2%
8/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
21.7%
18/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
17.6%
9/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.6%
4/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.6%
3/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.6%
1/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Headache
|
36.4%
12/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
27.7%
23/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
23.5%
12/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
18.0%
11/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.0%
5/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Paraesthesia
|
9.1%
3/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
7.8%
4/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.6%
4/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.0%
5/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.9%
3/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.6%
3/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Nervous system disorders
Tremor
|
0.00%
0/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.0%
5/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.9%
3/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Psychiatric disorders
Agitation
|
9.1%
3/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
4.8%
4/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.3%
2/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Psychiatric disorders
Anxiety
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
10.8%
9/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
9.8%
5/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
11.5%
7/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Psychiatric disorders
Depression
|
3.0%
1/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.0%
5/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Psychiatric disorders
Insomnia
|
15.2%
5/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
9.6%
8/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
13.1%
8/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Psychiatric disorders
Irritability
|
9.1%
3/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
9.6%
8/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
6.6%
4/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
|
Psychiatric disorders
Mood swings
|
6.1%
2/33 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
1.2%
1/83 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
0.00%
0/61 • Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
|
Additional Information
Clinical Trial Disclosure & Transparency
Jazz Pharmaceuticals
Phone: 215-832-3750
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place