Trial Outcomes & Findings for DS-3201b for Acute Myelogenous Leukemia (AML) or Acute Lymphocytic Leukemia (ALL) (NCT NCT03110354)
NCT ID: NCT03110354
Last Updated: 2024-01-31
Results Overview
Dose-limiting toxicity (DLT) is defined as a clinically significant non-hematologic treatment-emergent adverse event (TEAE) or abnormal clinical laboratory value that is clearly not related to disease progression, intercurrent illness, and occurring during the first cycle (28 days) on study that meets any of the following criteria: National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE), Version 4 Grade 3 aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), or bilirubin for ≥7 days; NCI-CTCAE Grade 4 AST (SGOT) or ALT (SGPT) of any duration; All Grade 4 non-hematologic toxicities of any duration; Any Grade 5 toxicity, unless proven to be clearly and incontrovertibly related to disease progression or intercurrent illness will constitute a DLT; All other clinically significant, non-hematological NCI-CTCAE Grade 3/4 AEs. AEs were coded using the MedDRA dictionary, Version 23.0.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Baseline up to Day 28
Results posted on
2024-01-31
Participant Flow
A total of 28 participants who met all inclusion criteria and no exclusion criteria were enrolled in Part 1 of the study. Due to slow enrollment, Part 2 of the study or Dose Expansion was not conducted. No results are reported for Part 2.
Participant milestones
| Measure |
DS-3201b 100mg
Participants who received 100 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 150 mg
Participants who received 150 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 250 mg
Participants who received 250 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 500 mg
Participants who received 500 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 700 mg
Participants who received 700 mg DS-3201b administered orally to participants with AML or ALL.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
3
|
10
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
3
|
10
|
7
|
Reasons for withdrawal
| Measure |
DS-3201b 100mg
Participants who received 100 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 150 mg
Participants who received 150 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 250 mg
Participants who received 250 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 500 mg
Participants who received 500 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 700 mg
Participants who received 700 mg DS-3201b administered orally to participants with AML or ALL.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Start of new therapy
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Failure to achieve response
|
2
|
3
|
0
|
2
|
1
|
|
Overall Study
Progressive disease
|
1
|
1
|
3
|
4
|
2
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
2
|
2
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
DS-3201b for Acute Myelogenous Leukemia (AML) or Acute Lymphocytic Leukemia (ALL)
Baseline characteristics by cohort
| Measure |
DS-3201b 100mg
n=4 Participants
Participants who received 100 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 150 mg
n=4 Participants
Participants who received 150 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 250 mg
n=3 Participants
Participants who received 250 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 500 mg
n=10 Participants
Participants who received 500 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 700 mg
n=7 Participants
Participants who received 700 mg DS-3201b administered orally to participants with AML or ALL.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 16.9 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 27.7 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 22.2 • n=5 Participants
|
54.6 years
STANDARD_DEVIATION 16.0 • n=4 Participants
|
55.9 years
STANDARD_DEVIATION 19.0 • n=21 Participants
|
57.9 years
STANDARD_DEVIATION 18.2 • n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 28Population: Dose-limiting toxicities were assessed in the DLT Evaluable Set.
Dose-limiting toxicity (DLT) is defined as a clinically significant non-hematologic treatment-emergent adverse event (TEAE) or abnormal clinical laboratory value that is clearly not related to disease progression, intercurrent illness, and occurring during the first cycle (28 days) on study that meets any of the following criteria: National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE), Version 4 Grade 3 aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), or bilirubin for ≥7 days; NCI-CTCAE Grade 4 AST (SGOT) or ALT (SGPT) of any duration; All Grade 4 non-hematologic toxicities of any duration; Any Grade 5 toxicity, unless proven to be clearly and incontrovertibly related to disease progression or intercurrent illness will constitute a DLT; All other clinically significant, non-hematological NCI-CTCAE Grade 3/4 AEs. AEs were coded using the MedDRA dictionary, Version 23.0.
Outcome measures
| Measure |
DS-3201b 100mg
n=3 Participants
Participants who received 100 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 150 mg
n=4 Participants
Participants who received 150 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 250 mg
n=3 Participants
Participants who received 250 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 500 mg
n=9 Participants
Participants who received 500 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 700 mg
n=6 Participants
Participants who received 700 mg DS-3201b administered orally to participants with AML or ALL.
|
|---|---|---|---|---|---|
|
Number of Participants With Any Grade Treatment-emergent Adverse Event Classified as Dose-limiting Toxicities (Dose Escalation)
Stomatitis, Any Grade
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Any Grade Treatment-emergent Adverse Event Classified as Dose-limiting Toxicities (Dose Escalation)
Any TEAE classified as DLT, Any Grade
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Any Grade Treatment-emergent Adverse Event Classified as Dose-limiting Toxicities (Dose Escalation)
Gastrointestinal disorders, Any Grade
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Any Grade Treatment-emergent Adverse Event Classified as Dose-limiting Toxicities (Dose Escalation)
Diarrhea, Any Grade
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Any Grade Treatment-emergent Adverse Event Classified as Dose-limiting Toxicities (Dose Escalation)
Blood and lymphatic system disorders, Any Grade
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Any Grade Treatment-emergent Adverse Event Classified as Dose-limiting Toxicities (Dose Escalation)
Bone marrow failure, Any Grade
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Any Grade Treatment-emergent Adverse Event Classified as Dose-limiting Toxicities (Dose Escalation)
Neoplasms benign, malignant, and unspecified (including cysts and polyps), Any Grade
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Any Grade Treatment-emergent Adverse Event Classified as Dose-limiting Toxicities (Dose Escalation)
Differentiation syndrome, Any Grade
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after last study dose, up to approximately 4 yearsPopulation: Treatment-emergent adverse events were assessed in the Safety Analysis Set.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug. AEs were coded using the MedDRA dictionary, Version 23.0.
Outcome measures
| Measure |
DS-3201b 100mg
n=4 Participants
Participants who received 100 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 150 mg
n=4 Participants
Participants who received 150 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 250 mg
n=3 Participants
Participants who received 250 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 500 mg
n=10 Participants
Participants who received 500 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 700 mg
n=7 Participants
Participants who received 700 mg DS-3201b administered orally to participants with AML or ALL.
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced Any Grade Treatment-emergent Adverse Event (Dose Escalation)
|
4 Participants
|
4 Participants
|
3 Participants
|
10 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Days 1 and 8 predose, 0.5, 1, 2, 4, 6, and 8 hours and Cycle 1 Day 15 postdose (each cycle is 28 days)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Pharmacokinetic parameters were assessed using noncompartmental methods.
Outcome measures
| Measure |
DS-3201b 100mg
n=4 Participants
Participants who received 100 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 150 mg
n=4 Participants
Participants who received 150 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 250 mg
n=3 Participants
Participants who received 250 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 500 mg
n=10 Participants
Participants who received 500 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 700 mg
n=7 Participants
Participants who received 700 mg DS-3201b administered orally to participants with AML or ALL.
|
|---|---|---|---|---|---|
|
Pharmacokinetic Parameter Maximum (Peak) Observed Concentration (Cmax) of DS-3201b
Cycle 1 Day 15
|
1.43 ug/mL
Standard Deviation 1.80
|
0.73 ug/mL
Standard Deviation 1.07
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter Maximum (Peak) Observed Concentration (Cmax) of DS-3201b
Cycle 1 Day 1
|
1.35 ug/mL
Standard Deviation 0.98
|
1.09 ug/mL
Standard Deviation 0.85
|
2.68 ug/mL
Standard Deviation 1.06
|
3.82 ug/mL
Standard Deviation 2.50
|
4.24 ug/mL
Standard Deviation 2.30
|
|
Pharmacokinetic Parameter Maximum (Peak) Observed Concentration (Cmax) of DS-3201b
Cycle 1 Day 8
|
—
|
—
|
3.69 ug/mL
Standard Deviation 1.22
|
4.31 ug/mL
Standard Deviation 1.84
|
5.31 ug/mL
Standard Deviation 1.93
|
SECONDARY outcome
Timeframe: Cycle 1 Days 1 and 8 predose, 0.5, 1, 2, 4, 6, and 8 hours and Cycle 1 Day 15 postdose (each cycle is 28 days)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Blood samples were collected for PK analysis. PK parameters were assessed using noncompartmental methods.
Outcome measures
| Measure |
DS-3201b 100mg
n=4 Participants
Participants who received 100 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 150 mg
n=4 Participants
Participants who received 150 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 250 mg
n=3 Participants
Participants who received 250 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 500 mg
n=10 Participants
Participants who received 500 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 700 mg
n=7 Participants
Participants who received 700 mg DS-3201b administered orally to participants with AML or ALL.
|
|---|---|---|---|---|---|
|
Pharmacokinetic Parameter Time to Maximum Observed Concentration (Tmax) of DS-3201b
Cycle 1 Day 1
|
3.03 hours
Interval 2.0 to 4.25
|
4.06 hours
Interval 0.0 to 20.22
|
4.07 hours
Interval 2.17 to 4.18
|
3.81 hours
Interval 0.0 to 4.27
|
2.22 hours
Interval 1.02 to 8.0
|
|
Pharmacokinetic Parameter Time to Maximum Observed Concentration (Tmax) of DS-3201b
Cycle 1 Day 15
|
2.00 hours
Interval 1.0 to 2.25
|
0 hours
Interval 0.0 to 2.08
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter Time to Maximum Observed Concentration (Tmax) of DS-3201b
Cycle 1 Day 8
|
—
|
—
|
3.97 hours
Interval 2.03 to 4.0
|
4.03 hours
Interval 1.03 to 6.25
|
3.07 hours
Interval 0.68 to 7.97
|
SECONDARY outcome
Timeframe: Cycle 1 Days 1 and 8 predose, 0.5, 1, 2, 4, 6, and 8 hours and Cycle 1 Day 15 postdose (each cycle is 28 days)Population: Pharmacokinetic parameters were assessed in participants with available data in the Pharmacokinetic Analysis Set.
Blood samples were collected for PK analysis. Area under the plasma concentration-time curve up to 24 hours (AUC24h) and area under the plasma concentration-time curve up to the last measurable concentration (AUClast) were assessed using noncompartmental methods.
Outcome measures
| Measure |
DS-3201b 100mg
n=4 Participants
Participants who received 100 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 150 mg
n=3 Participants
Participants who received 150 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 250 mg
n=3 Participants
Participants who received 250 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 500 mg
n=9 Participants
Participants who received 500 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 700 mg
n=7 Participants
Participants who received 700 mg DS-3201b administered orally to participants with AML or ALL.
|
|---|---|---|---|---|---|
|
Pharmacokinetic Parameter Area Under Plasma Concentration-Time Curve of DS-3201b
Cycle 1 Day 1: AUC24h
|
8.97 h*ug/mL
Standard Deviation 6.98
|
9.27 h*ug/mL
|
19.83 h*ug/mL
Standard Deviation 4.71
|
43.13 h*ug/mL
Standard Deviation 26.69
|
51.05 h*ug/mL
Standard Deviation 26.55
|
|
Pharmacokinetic Parameter Area Under Plasma Concentration-Time Curve of DS-3201b
Cycle 1 Day 15: AUC24h
|
2.90 h*ug/mL
Standard Deviation 1.71
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter Area Under Plasma Concentration-Time Curve of DS-3201b
Cycle 1 Day 8: AUC24h
|
—
|
—
|
—
|
46.34 h*ug/mL
Standard Deviation 37.24
|
34.87 h*ug/mL
Standard Deviation 2.36
|
|
Pharmacokinetic Parameter Area Under Plasma Concentration-Time Curve of DS-3201b
Cycle 1 Day 1: AUClast
|
7.79 h*ug/mL
Standard Deviation 4.05
|
11.32 h*ug/mL
Standard Deviation 7.62
|
19.79 h*ug/mL
Standard Deviation 4.88
|
37.28 h*ug/mL
Standard Deviation 23.64
|
41.58 h*ug/mL
Standard Deviation 27.91
|
|
Pharmacokinetic Parameter Area Under Plasma Concentration-Time Curve of DS-3201b
Cycle 1 Day 15: AUClast
|
5.09 h*ug/mL
Standard Deviation 6.01
|
8.23 h*ug/mL
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter Area Under Plasma Concentration-Time Curve of DS-3201b
Cycle 1 Day 8: AUClast
|
—
|
—
|
19.91 h*ug/mL
Standard Deviation 4.85
|
20.75 h*ug/mL
Standard Deviation 11.54
|
24.77 h*ug/mL
Standard Deviation 11.70
|
SECONDARY outcome
Timeframe: Cycle 1 Day 2 postdose (each cycle is 28 days)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set in participants with available data.
Blood samples were collected for PK analysis. PK parameters were assessed using noncompartmental methods.
Outcome measures
| Measure |
DS-3201b 100mg
n=4 Participants
Participants who received 100 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 150 mg
n=4 Participants
Participants who received 150 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 250 mg
n=3 Participants
Participants who received 250 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 500 mg
n=9 Participants
Participants who received 500 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 700 mg
n=7 Participants
Participants who received 700 mg DS-3201b administered orally to participants with AML or ALL.
|
|---|---|---|---|---|---|
|
Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of DS-3201b
|
0.09 ug/mL
Standard Deviation 0.05
|
0.58 ug/mL
Standard Deviation 0.98
|
0.33 ug/mL
Standard Deviation 0.11
|
0.64 ug/mL
Standard Deviation 0.46
|
0.84 ug/mL
Standard Deviation 0.76
|
Adverse Events
DS-3201b 100mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 4 deaths
DS-3201b 150 mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
DS-3201b 250 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
DS-3201b 500 mg
Serious events: 7 serious events
Other events: 9 other events
Deaths: 10 deaths
DS-3201b 700 mg
Serious events: 6 serious events
Other events: 7 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
DS-3201b 100mg
n=4 participants at risk
Participants who received 100 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 150 mg
n=4 participants at risk
Participants who received 150 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 250 mg
n=3 participants at risk
Participants who received 250 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 500 mg
n=10 participants at risk
Participants who received 500 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 700 mg
n=7 participants at risk
Participants who received 700 mg DS-3201b administered orally to participants with AML or ALL.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
28.6%
2/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
General disorders
Disease progression
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
30.0%
3/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
28.6%
2/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Infections and infestations
Pneumonia
|
75.0%
3/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Nervous system disorders
Hemorrhage intracranial
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
28.6%
2/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Differentiation syndrome
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Infections and infestations
Periorbital infection
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
Other adverse events
| Measure |
DS-3201b 100mg
n=4 participants at risk
Participants who received 100 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 150 mg
n=4 participants at risk
Participants who received 150 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 250 mg
n=3 participants at risk
Participants who received 250 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 500 mg
n=10 participants at risk
Participants who received 500 mg DS-3201b administered orally to participants with AML or ALL.
|
DS-3201b 700 mg
n=7 participants at risk
Participants who received 700 mg DS-3201b administered orally to participants with AML or ALL.
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Investigations
Serum ferritim increased
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
28.6%
2/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
71.4%
5/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
28.6%
2/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
40.0%
4/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
28.6%
2/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
28.6%
2/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Dysgeusia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
40.0%
4/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
28.6%
2/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Headache
|
50.0%
2/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
42.9%
3/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Psychiatric disorders
Anxiety
|
50.0%
2/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Psychiatric disorders
Depression
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Psychiatric disorders
Dysphoria
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
30.0%
3/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
30.0%
3/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
42.9%
3/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
28.6%
2/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
2/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
42.9%
3/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Investigations
Blast cell count increased
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Oral pain
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Cardiac disorders
Tachycardia
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Ear and labyrinth disorders
Ear swelling
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Ear and labyrinth disorders
Otorrhea
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Eye disorders
Extraocular muscle disorder
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
28.6%
2/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
66.7%
2/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
40.0%
4/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
57.1%
4/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Gingival bleeding
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Melaena
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
40.0%
4/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
57.1%
4/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
60.0%
6/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
42.9%
3/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
General disorders
Asthenia
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
General disorders
Chills
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
28.6%
2/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
General disorders
Face oedema
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
28.6%
2/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
General disorders
Feeling hot
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
General disorders
Malaise
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
28.6%
2/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
General disorders
Pain
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
General disorders
Peripheral swelling
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
General disorders
Swelling face
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Infections and infestations
Herpes virus infection
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Infections and infestations
Stomatococcal infection
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Investigations
Coronavirus test positive
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from baseline up to 30 days after last study dose, up to approximately 4 years.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place